chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Muscle enzyme, Pain, Pain in extremity
Clinical narrative: Became fatigued and achy soon after at the grocery store. Went home. Slept in Lazy Boy Chair for 3 hours. Whole right side of my body ached from neck to feet, including arm and fingers. Started limping when I stood up. Took two Aspirin. Body continued to ache through Sunday, Monday and was sleep disturbed. By Thursday only leg ached and I continued to limp. Woke Friday morning in a lot of pain (cleaned house the day before), had trouble sleeping in the night. Applied sports cream at midnight. Continued to take aspirin. Went to urgent care to make sure nothing more serious was going on. Dr. electrolyte scan and checked for a muscle enzyme. He said the tests were normal (October 10).Leg is still hurting including knee. Hard to carry on normal movement and hard to drive a car.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Body temperature increased, Chest X-ray, Electrocardiogram
Clinical narrative: Temp of 102.F, backache, severe joint aches, fatigue, headache, and "beet red" face.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Headache, White blood cell count
Clinical narrative: Temp of 102.F, backache, severe joint aches, fatigue, headache, and "beet red" face.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Tremor
Clinical narrative: I had a bad dizzy spell that lasted about 2 hours and horrible shaking that has been going on more then 5 hours now without improving.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria, Vomiting
Clinical narrative: Patient was screened for adverse reaction prior to flu administration at the mass flu shot and had indicated he had a adverse reaction as a child of age 5 with vomiting and hives.  Pt was screened by provider and was recommended to give shot. Pt was given Afluria LOT #T59406 EXP: 30Jun15 in L arm using a 25G needle in the L arm and observed for symptoms.  Approx 10 min later pt developed several small hives localized in area of injection.  50 mg of Benadryl was administered and soldier was placed on monitor. Vital signs remained stable and pt was released without further reaction.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Crying, Dysphagia, Dysphonia
Clinical narrative: Coughing, hoarseness, swelling of my throat (difficulty swallowing), painful itchy red eyes, weeping of my eyes and nose, bloodshot eyes, severe chills and aches of my body, severe headache, high fever (102.2 while on ibuprofen).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Eye pruritus, Headache, Ocular hyperaemia, Pain
Clinical narrative: Coughing, hoarseness, swelling of my throat (difficulty swallowing), painful itchy red eyes, weeping of my eyes and nose, bloodshot eyes, severe chills and aches of my body, severe headache, high fever (102.2 while on ibuprofen).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pyrexia, Rhinorrhoea
Clinical narrative: Coughing, hoarseness, swelling of my throat (difficulty swallowing), painful itchy red eyes, weeping of my eyes and nose, bloodshot eyes, severe chills and aches of my body, severe headache, high fever (102.2 while on ibuprofen).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood test, Fatigue, Inflammation, Pain
Clinical narrative: Fatigue and a few days later severe joint pain. 09/30/2014 doctor prescribed Naproxen 500 mg for pain and inflammation. No result so 10/8/2014 returned to doctor to have blood drawn and received steroid shot. Steroid shot has so far ended the joint pain. Hope it is a permanent fix.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Headache, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Started with chills, next day fever, chills, headache, muscle ache, large red patch at shot injection site. 3rd day same, 4th day, fever, chills, headache went away.  Shot site redness larger and extremly sore to touch. Applied cold cloths, massage area.  Week later, shot site still sore, redness slowly going away.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Tenderness
Clinical narrative: Started with chills, next day fever, chills, headache, muscle ache, large red patch at shot injection site. 3rd day same, 4th day, fever, chills, headache went away.  Shot site redness larger and extremly sore to touch. Applied cold cloths, massage area.  Week later, shot site still sore, redness slowly going away.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Throat tightness, Wheezing
Clinical narrative: Coughing and felt like throat was closing.  Around 1 am woke wheezing and felt pressure on her chest, difficulty breathing.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema, Pain of skin, Skin warm
Clinical narrative: Below injection site, skin became erythematous, painful, edematous with increased warmth.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Allergy to vaccine, Cellulitis, Diarrhoea, Hypersensitivity, Injection site erythema
Clinical narrative: Below injection site, skin became erythematous, painful, edematous with increased warmth.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site urticaria
Clinical narrative: Below injection site, skin became erythematous, painful, edematous with increased warmth.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: Nausea, Lightheadedness, Flushing.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe sore arm that last more than 1 week.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation, Electrocardiogram, Heart rate increased
Clinical narrative: Pt reported rapid heart beat. presented to MD office, where he was told he had Atrial Fibrillation which was likely precipitated due to the Fluzone HD vaccine given the day before. He then came to pharmacy to report the reaction to the pharmacist. He is under care of his physician for the AFib.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Soreness, increasing warmth. After a few days it looked like bug bite swelling and was getting worse. Took Benadryl to try and stop reaction.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Borrelia test, Pain, Pain of skin
Clinical narrative: Body/joint aches and skin soreness.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Exteme itching, redness and swelling. Pt also had fever, chills and aches.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Swelling
Clinical narrative: Exteme itching, redness and swelling. Pt also had fever, chills and aches.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Dizziness, Dysphonia, Fatigue, Oropharyngeal pain
Clinical narrative: I felt achy and fatigue on Monday evening, the night of the shot.  I felt achy, fatigue and my throat began to hurt on Tuesday.  On Wednesday (three days after the shot,) my throat hurt and my voice started to become horse.  Thursday, my voice was so horse it hurt to talk.  Friday, I stayed home from work because I couldn't really talk at all.  I felt fatigue, dizziness and achy.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: I felt achy and fatigue on Monday evening, the night of the shot.  I felt achy, fatigue and my throat began to hurt on Tuesday.  On Wednesday (three days after the shot,) my throat hurt and my voice started to become horse.  Thursday, my voice was so horse it hurt to talk.  Friday, I stayed home from work because I couldn't really talk at all.  I felt fatigue, dizziness and achy.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: 5 hours status post vaccination, c/o facial itching.  Itching slowly started on neck, and arm.  Slight hives noted on R arm, back and near L chest area.  NO difficulty breathing, no noted stridor.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Headache, Influenza like illness, Injection site pain
Clinical narrative: Extreme soreness at injection site (right arm) no redness was visible. As the evening progressed this developed into extreme weakness in the right arm, almost complete inability to lift the arm. This then developed into overall body soreness in all joints but especially lower back, neck and knees along with fever and headache. Basically extreme flu like symptoms with the extreme soreness and weakness of the right arm.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Muscular weakness, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme soreness at injection site (right arm) no redness was visible. As the evening progressed this developed into extreme weakness in the right arm, almost complete inability to lift the arm. This then developed into overall body soreness in all joints but especially lower back, neck and knees along with fever and headache. Basically extreme flu like symptoms with the extreme soreness and weakness of the right arm.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Shoulder stiffness on arm of injection. Patient presented to pharmacy on 10/10/2014 and reported pain and stifness that resulted in patient not being able to lift her arm.
Age: 0.24
Sex: M
Vaccine: RVX
Symptoms: Dehydration, Diarrhoea, Pain, Screaming
Clinical narrative: Patient received the rotavirus vaccine and had extreme pain within 24 hours of the vaccine. He had severe diarrhea. He was screaming uncontrollably. I took him to the doctor's office and the doc said he may be having his intussusception, where his intestines flip inside out???? I took patient to the ER, where they found no evidence of intestinal damage, but he was dehydrated from the diarrhea.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Rash, Upper extremity mass
Clinical narrative: Pt was having a rash and swelling in both arms (had flu vaccine in 1 arm and pneumonia vaccine in other arm). Pt also had a lump in right arm.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Body temperature, Cough, Dyspnoea, Heart rate increased
Clinical narrative: Coughing, soreness in throat due to blisters, difficulty in breathing, fast heartbeat, nausea for about 20 minutes before going to Emergency Room. ER gave me Benadryl tablet, shot of dexamethasone.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal blistering, Oropharyngeal pain
Clinical narrative: Coughing, soreness in throat due to blisters, difficulty in breathing, fast heartbeat, nausea for about 20 minutes before going to Emergency Room. ER gave me Benadryl tablet, shot of dexamethasone.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient said the vaccination hurt when it was given. I told her that her arm may be sore for a couple of days.  On 10/9/14 the patient called and said that her arm was still sore and the soreness was moving up to her neck. The pharmacist that was talking to her told her to notify her doctor.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm where shot was given was red, swollen and warm to the touch.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Dizziness, Feeling hot, Hypoaesthesia, Injection site pain
Clinical narrative: Burning from injection site down to the inside of the bend of my elbow. Got up to let the staff know and had hot shooting pain up my neck. Then I was dizzy and felt faint and like I was going to vomit. The staff took me to the back and the doctor checked me out. During this time I was unable to see anything but shadows. My vision returned in about 10 minutes. I continued with numbness and tingling and was discharged home. It is now 2054 and I am still having symptoms. It feels like what is under my skin is on fire and the itchy. It is miserable. At times my lungs, heart, and intestines have felt as if they have been burned. My throat feels like a swallowed acid. I hope this ends soon.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Neck pain, Paraesthesia, Pruritus, Throat irritation
Clinical narrative: Burning from injection site down to the inside of the bend of my elbow. Got up to let the staff know and had hot shooting pain up my neck. Then I was dizzy and felt faint and like I was going to vomit. The staff took me to the back and the doctor checked me out. During this time I was unable to see anything but shadows. My vision returned in about 10 minutes. I continued with numbness and tingling and was discharged home. It is now 2054 and I am still having symptoms. It feels like what is under my skin is on fire and the itchy. It is miserable. At times my lungs, heart, and intestines have felt as if they have been burned. My throat feels like a swallowed acid. I hope this ends soon.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Visual impairment
Clinical narrative: Burning from injection site down to the inside of the bend of my elbow. Got up to let the staff know and had hot shooting pain up my neck. Then I was dizzy and felt faint and like I was going to vomit. The staff took me to the back and the doctor checked me out. During this time I was unable to see anything but shadows. My vision returned in about 10 minutes. I continued with numbness and tingling and was discharged home. It is now 2054 and I am still having symptoms. It feels like what is under my skin is on fire and the itchy. It is miserable. At times my lungs, heart, and intestines have felt as if they have been burned. My throat feels like a swallowed acid. I hope this ends soon.
Age: 0.75
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Febrile convulsion, Full blood count normal, Urine analysis normal
Clinical narrative: Febrile seizure with temp to 102.7 without other source for infection, normal CBC, U/A.
Age: 0.75
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Differential white blood cell count normal, Febrile convulsion, Full blood count normal, Grand mal convulsion
Clinical narrative: Febrile seizure with temp to 102.7 without other source for infection, normal CBC, U/A.
Age: 0.75
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Postictal state, Resuscitation, Sluggishness, Urine analysis normal
Clinical narrative: Febrile seizure with temp to 102.7 without other source for infection, normal CBC, U/A.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Cough, sore throat, low grade fever.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cough, Dysphagia, Dyspnoea, Oropharyngeal pain
Clinical narrative: Within the hour from 5:00- 6:00 PM. My throat became sore and swollen making swallowing difficult (was asymptomatic up until that time). Asthma like cough developed and breathing became an effort. At 6:15PM I took one 25mg Benadryl thinking it could be an allergic reaction. By 7:00 PM I was feeling relief and breathing easy. Throat remains feeling slightly "tight" but continues to improve.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Throat tightness
Clinical narrative: Within the hour from 5:00- 6:00 PM. My throat became sore and swollen making swallowing difficult (was asymptomatic up until that time). Asthma like cough developed and breathing became an effort. At 6:15PM I took one 25mg Benadryl thinking it could be an allergic reaction. By 7:00 PM I was feeling relief and breathing easy. Throat remains feeling slightly "tight" but continues to improve.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Discomfort, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Was administered w/out patient's knowledge or prior consent the "Fluzone High Dose" seasonal flu vaccine instead of a regular flu vaccine, resulting in: -High fever w/ extreme perspiring -Severe vomiting -Diarrhea -Some "shakiness" -Inability to get into any comfortable position.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Was administered w/out patient's knowledge or prior consent the "Fluzone High Dose" seasonal flu vaccine instead of a regular flu vaccine, resulting in: -High fever w/ extreme perspiring -Severe vomiting -Diarrhea -Some "shakiness" -Inability to get into any comfortable position.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling face
Clinical narrative: Face swelled up for 3 weeks!!
Age: 68.0
Sex: F
Vaccine: JEV1, JEV1
Symptoms: Erythema, Furuncle, Rash generalised
Clinical narrative: Red boils on right arm, rash of inside left and right legs - rash on face, neck and stomach last 14 days.
Age: 68.0
Sex: F
Vaccine: JEV1, JEV1
Symptoms: Erythema, Furuncle, Rash
Clinical narrative: Red boils on right arm, rash of inside left and right legs - rash on face, neck and stomach last 14 days.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Limited range of motion, pain in left deltoid, scale of 1-10 patient states an 8 upon movement, 5 at rest.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Limited range of motion, pain in left deltoid, scale of 1-10 patient states an 8 upon movement, 5 at rest.
Age: 2.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: Swelling and pain - left upper arm and spread to upper part of lower arm.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Allergy to vaccine, Erythema, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: 9/15 Pt rec'd PNEUMOVAX in (R) arm, FLUZONE HD in left. 9/16 (R) arm painful to pt near injection site. 9/17 (R) arm red and a bit swollen at 11AM, warm, not painful. 9/17 groin, perineum, both thighs and (R) arm shoulder to elbow and (L) arm wrist to elbow red by 2PM. 9/21 rash resolved (still sm amt redness perineum).
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: 9/15 Pt rec'd PNEUMOVAX in (R) arm, FLUZONE HD in left. 9/16 (R) arm painful to pt near injection site. 9/17 (R) arm red and a bit swollen at 11AM, warm, not painful. 9/17 groin, perineum, both thighs and (R) arm shoulder to elbow and (L) arm wrist to elbow red by 2PM. 9/21 rash resolved (still sm amt redness perineum).
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Local swelling, Rash
Clinical narrative: 9/15 Pt rec'd PNEUMOVAX in (R) arm, FLUZONE HD in left. 9/16 (R) arm painful to pt near injection site. 9/17 (R) arm red and a bit swollen at 11AM, warm, not painful. 9/17 groin, perineum, both thighs and (R) arm shoulder to elbow and (L) arm wrist to elbow red by 2PM. 9/21 rash resolved (still sm amt redness perineum).
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Skin warm
Clinical narrative: 9/15 Pt rec'd PNEUMOVAX in (R) arm, FLUZONE HD in left. 9/16 (R) arm painful to pt near injection site. 9/17 (R) arm red and a bit swollen at 11AM, warm, not painful. 9/17 groin, perineum, both thighs and (R) arm shoulder to elbow and (L) arm wrist to elbow red by 2PM. 9/21 rash resolved (still sm amt redness perineum).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Chills, fever (102.8), aches, headache, fatigue - sick in bed 24 hrs, nausea. Treated with acetaminophen. Had low grade fever an additional 24 hrs. Didn't feel 100% for 3 days from onset.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, fever (102.8), aches, headache, fatigue - sick in bed 24 hrs, nausea. Treated with acetaminophen. Had low grade fever an additional 24 hrs. Didn't feel 100% for 3 days from onset.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Pt had swelling, redness and fever started soon after immunization. On 9-30-14 went to clinic and given KEFLEX 500mg take for 10 days.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Alopecia, Hair colour changes
Clinical narrative: Patient says having "alopecia" (ie bald spots) in his beard, hair is starting to grow back in bald patches but is growing back a lighter color rest of beard is dark - said started after getting flu shot.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness left deltoid 4 x3 warm feeling and itch.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Vision blurred
Clinical narrative: Patient reported dizziness, blurry vision and stomach upset. Followed up with pt hours later and father said she recovered. Maybe anxiety related.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation
Clinical narrative: Pt states inflammation injection site right delt PNEUMOVAX 23 (IM).
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out after 2nd injection. 1st PNEUMOVAX 23 2d was AFLURIA. Pt stated to me after the fact "I sometimes pass out after a injection."
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Approx 3:20 PM pt received vaccine, after 5 min pt felt lightheaded and slightly dizzy. Had pt lie down flat, RN on staff checked pulse. Pulse regular, no abnormal signs observed. 3:50 pt's dizziness was completely resolved. No lightheadedness, pulse regular.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Frostbite, Induration, Pain in extremity, Pruritus
Clinical narrative: (R) arm became severely painful, induration. erythematous; next day measuring 4 inches diameter; diameter was serpiginous in shape; ice-burned areas; 3 days later swelling subsided, pruritus developed.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: (R) arm became severely painful, induration. erythematous; next day measuring 4 inches diameter; diameter was serpiginous in shape; ice-burned areas; 3 days later swelling subsided, pruritus developed.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Patient developed swelling in axillary lymph nodes in arm where vaccine was administered.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Reports raised warm area left deltoid injection site, fever, chills, nausea and vomiting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Reports raised warm area left deltoid injection site, fever, chills, nausea and vomiting.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Swelling on the site of injection and redness traveling to the arm (whole arm).
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Nodule, Pain, Skin warm
Clinical narrative: Pt reports knot in arm that was hot, raised and painful.
Age: 1.02
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Dry skin, Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: Area on lt lateral leg - red rough, non tender area - 3 cm x 1 1/4 - at site of varicella - onset 10/6/14. Followed by wide spread red, papular rash, temp - 102.4 - onset 10/5. Duration 4 days.
Age: 1.02
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Rash papular
Clinical narrative: Area on lt lateral leg - red rough, non tender area - 3 cm x 1 1/4 - at site of varicella - onset 10/6/14. Followed by wide spread red, papular rash, temp - 102.4 - onset 10/5. Duration 4 days.
Sex: U
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: 1 month Influenza vaccine adm to right upper lat. arm, pain and worsening limitation to ROM of shoulder, now inability to move (R) shoulder.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed injection site reactions such as redness, pain and swelling within 24 hrs of the shot. Pt went to hospital (ER) and doctor gave her BENADRYL. Pt too acetaminophen before going to hospital.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on arms and legs.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis (L) arm (redness, swelling, pain, hot to touch) on most of upper arm. Diagnosed by primary care provider. Treatment: Clindamycin 300mg three times daily.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in jaw, Tenderness
Clinical narrative: After flu shot patient had jaw soreness/tenderness that evening on right side. Received shot in right arm.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Patient received flu shot. She got up and watch mother receive hers. Her and her mom walked out of pharmacy. Rph noticed they sat back down. Rph went to them. Daughter was hot and sweaty. She looked pale. She threw up in waste basket. Mother said she looked pale. Patient received flu shot around 12:00 pm. She got up. Her mother received hers. She watched mom get her flu shot immediately after hers. Her and her mom walked out of pharmacy. I (the Rph) noticed them sit back down. I went to them. Mom said daughter felt dizzy and was sweaty and pale. Daughter look pale and was "pasty". Daughter felt nauseous. Mom gave her a waste basket and she threw up. I felt her skin and it was cool and pasty. Injection site looked normal. After about 10-15 mins. daughter looked like she got her color back. I observed her until she felt better. Mom was confident she was ok and walked out with her. I called mom 2 hours later and daughter went to work and felt back to normal and ate something when she got home.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Vomiting
Clinical narrative: Patient received flu shot. She got up and watch mother receive hers. Her and her mom walked out of pharmacy. Rph noticed they sat back down. Rph went to them. Daughter was hot and sweaty. She looked pale. She threw up in waste basket. Mother said she looked pale. Patient received flu shot around 12:00 pm. She got up. Her mother received hers. She watched mom get her flu shot immediately after hers. Her and her mom walked out of pharmacy. I (the Rph) noticed them sit back down. I went to them. Mom said daughter felt dizzy and was sweaty and pale. Daughter look pale and was "pasty". Daughter felt nauseous. Mom gave her a waste basket and she threw up. I felt her skin and it was cool and pasty. Injection site looked normal. After about 10-15 mins. daughter looked like she got her color back. I observed her until she felt better. Mom was confident she was ok and walked out with her. I called mom 2 hours later and daughter went to work and felt back to normal and ate something when she got home.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Gastrooesophageal reflux disease, Injection site erythema, Injection site warmth
Clinical narrative: Erythemic patch (10 x 7.5 cm) on upper (R) arm circumferentially. Warm to touch. Does not itch. Takes Ranitidine 150mg twice daily for GERD.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Hand of vaccinated arm swollen but not area of injection site.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Softball size soreness around injection site and redness from injection site down to elbow.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Softball size soreness around injection site and redness from injection site down to elbow.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness 5 cm, soreness, swelling.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Pt complained of redness around injection site. She was prescribed BACTRIM antibiotics. The redness was on her left arm.
Age: 30.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Reddened, slightly swollen, itchy area around site x 3 days. Slightly larger than a quarter.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Redness around the area, inflammation and warmness at site of injection. It occurred around 12 pm the night of the immunization. Patient had flu shot before with pharmacy without any reactions.
Age: 64.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours later, red and hard lump at injection site (swelling) peaked at 3rd day, not "pain" more itching and redness and warm to touch 6" x 3" rectangle red area - all in right arm - ADACEL injection site.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: Patient states excruciating arm pain unrelieved by heat or ibuprofen. Pain continued and grew steadily worse. Area was red and swollen. Swelling grew worse to below elbow and patient could not straighten arm. Pt. went to MD and was given steroids and antihistamines. Pt much better and feels she got a bad vial.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal discomfort, Pain
Clinical narrative: Discomfort in (L) shoulder almost immediately that got worse over the next few days. Went to Dr on 9/6/14, received oral steroids that helped some but pain has continued even Kw/ a steroid injection and physical therapy.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Night sweats, Pain, Pruritus
Clinical narrative: Patient states that her arm was itching, she feels aching, her eye was itching and sweat at night. She woke up with swollen eyes and went to emergency room.
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Dizziness, Eructation, Feeling hot, Gastrooesophageal reflux disease, Nausea
Clinical narrative: Approximately 40 minutes after flu shot c/o feeling warm head tightness around entire head and dizziness. Nausea radiated into mid chest area and throat. Belching with acid reflux denied Hx of Acid Reflux. 10/10/14 appt cx per pt. "Working today and feel fine."
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Tension headache
Clinical narrative: Approximately 40 minutes after flu shot c/o feeling warm head tightness around entire head and dizziness. Nausea radiated into mid chest area and throat. Belching with acid reflux denied Hx of Acid Reflux. 10/10/14 appt cx per pt. "Working today and feel fine."
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Pyrexia
Clinical narrative: Low grade T (100) x 7d; (L) arm erythema day 6-8.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Client reports when he got the HIGH DOSE flu injection he noted that it immediately burned "it felt like boiling water being injected". Reports that after vaccination he ran some errands, went for a four mile walk and noted he started to feel "like someone beat him up". Took a long nap and woke up with "scratchy eyes, body aches and a severe headache. Went to bed. Woke up the next day noted that body aches were gone but the headache persisted that day. 10/09 felt better and today only has some burning at the sight but no other symptoms. Was worried as he has had injections including a yearly flu vaccine and was has never reacted like this until getting the HIGH DOSE vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Client reports when he got the HIGH DOSE flu injection he noted that it immediately burned "it felt like boiling water being injected". Reports that after vaccination he ran some errands, went for a four mile walk and noted he started to feel "like someone beat him up". Took a long nap and woke up with "scratchy eyes, body aches and a severe headache. Went to bed. Woke up the next day noted that body aches were gone but the headache persisted that day. 10/09 felt better and today only has some burning at the sight but no other symptoms. Was worried as he has had injections including a yearly flu vaccine and was has never reacted like this until getting the HIGH DOSE vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red, swollen, painful area near injection site. Lasted 4 days. Patient recovered fully.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Right arm lots of pain and into shoulder and neck and very nauseated. Site just a little red.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Vaccine was given 1:20 pm on 10/10/2014. Pt came back after 1 hr with symptoms of nausea and vomiting. Pt was taken to nearby hospital.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: 10:10 FLUZONE HIGH DOSE was given. Pt stated at 12:00 noon he started to have muscle ache, nausea and chills for the rest of the day. Next day (9/20/14) just headache. Sunday (9/21/14) pt felt fine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Received vaccine FLULAVAL IIV midmorning. Within 2-3 hours developed fever, chills and severe headache with severe nausea which lasted approx 30 hours. Max fever 101. Telephone report by pt to immunization healthcare provider.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Injection site infection, Rash, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Pt states that site pf administration for flu vaccine was not cleaned with an alcohol pad prior to administration. That evening pt noticed rash and went to ER, where she was informed that she got a staph infection at the site of flu vaccine administration. Treated with KEFLEX.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: After injection pt began to swell at the site of injection only. Had patient wait for approx 30 minutes before leaving. She said that she felt fine no rash, itching on hives or difficulty breathing.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia
Clinical narrative: Left pinky tingling about 1 week after vaccination.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Left pinky tingling about 1 week after vaccination.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Malaise, Nausea, Vomiting
Clinical narrative: Phone call from vaccine recipient, reports 30 min, approx. after immunization, had headache, nausea, vomiting, no fever, still feeling ill today - has had flu vax before with (-) problems - he to consult with dr.
Age: 41.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus, Rash, Swelling, Vaccination site reaction
Clinical narrative: Rash, itching swelling txt self with BENADRYL and hydrocortisone creme. Seen on 9/29/14 with no rxn at vaccine site. Rash w back of shoulder (states vaccine site rxn had previously cleared.).
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Influenza like illness, Swelling
Clinical narrative: Vaccine administered 9/30 in afternoon. Immediate bump approx 1" from skin. No pain/burning. 6 pm - pt had flu-like sx and went to ER. Treated and released.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal disorder, Musculoskeletal pain, Neck pain
Clinical narrative: Patient experienced extreme neurological pain in shoulder, radiating through neck, numbness in extremities, and loss of use in the left arm w/i days after the shot. He saw his PCP, was scolded for using "people that don't know what they're doing" and told to use a hot compress.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient's daughter called the pharmacy and spoke to (staff pharmacist). Patient's daughter reported that patient is experiencing redness, swelling, pain on her left arm after receiving the PNEUMOVAX. We have been trying to get a hold of the patient yesterday but did not hear from them yet. Recommended that patient sees a doctor as soon as possible.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Erythema, Local swelling, Musculoskeletal pain, Nasopharyngitis
Clinical narrative: About 3" dia, red swollen area on left arm. Lot of pain, cold symptoms - going on for 4 days now. Pain in shoulder area. Fever and SOB and throat closing.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia, Throat tightness
Clinical narrative: About 3" dia, red swollen area on left arm. Lot of pain, cold symptoms - going on for 4 days now. Pain in shoulder area. Fever and SOB and throat closing.
Age: 27.0
Sex: F
Vaccine: ANTH, FLUN4
Symptoms: Headache
Clinical narrative: Developed LLR that spread to her axilla and intermittent headaches.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness, Upper extremity mass
Clinical narrative: Left arm, large raised red lump, 2x3 warm to touch, tender.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood magnesium normal, Blood potassium decreased, Blood thyroid stimulating hormone normal, Computerised tomogram head, Electrocardiogram
Clinical narrative: Received HD injection, next day had high blood pressure, tinnitus, nausea, headache. Went to E.D. Had CBC, CMP, UA, TSH, Head CT, EKG. Discharged. To PCP for follow up 10/9/14 feeling baseline again. Rx Potassium and magnesium replacement.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Headache, Hypertension, Metabolic function test, Nausea
Clinical narrative: Received HD injection, next day had high blood pressure, tinnitus, nausea, headache. Went to E.D. Had CBC, CMP, UA, TSH, Head CT, EKG. Discharged. To PCP for follow up 10/9/14 feeling baseline again. Rx Potassium and magnesium replacement.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Urine analysis
Clinical narrative: Received HD injection, next day had high blood pressure, tinnitus, nausea, headache. Went to E.D. Had CBC, CMP, UA, TSH, Head CT, EKG. Discharged. To PCP for follow up 10/9/14 feeling baseline again. Rx Potassium and magnesium replacement.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Localized redness and swelling. Warm to touch.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergie was specified. On an unkonwn date in September 2014 over the past 3 to 4 weeks, the patients were vaccinated with GARDASIL (lot#, dose, route not reported). No concomitant medications were reported. No symptoms reported. There was no product quality complaint. The outcome is unknown. This is one of the three reports received from the same reporter (MARRS # 1410USA005091 and MARRS # 1410USA005092). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Chest pain
Clinical narrative: This spontaneous report as received from a pharmacist of unknown age via a company representative refers to herself who was not pregnant. On an unknown date the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (lot #, strength, dose and route unspecified). She developed pain and burning 1 week later in her thoracic region and was assessed by her physician and diagnosed with possible shingles and prescribed Acyclovir on an unspecified date. The outcome of the event was reported as recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No information about medical history, drug reactions and allergies was specified. On 01-OCT-2014 the patient was vaccinated with PROQUAD (lot # K005644, expiry: 17-OCT-2015, dose 0.5 ml once), subcutaneous that was improperly stored at 6 Fahrenheit for 30 minutes. No concomitant medications were reported. No adverse effects reported. There was no product quality complaint. The outcome is unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history was not reported. On an unknown date these unspecified amount of patients were vaccinated with M-M-R II (lot #, dose and route were not reported), that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported.   Follow up has been received from nurse who stated that the lots numbers involved in the case for the M-M-R II was: J011332, expiration date: 13-SEP-2015.   Follow up information was received from the nurse. After temperature excursion vaccines were verified as stable. On 21-AUG-2014 at 16:19, multiple patients were vaccinated with M-M-R II (lot number J011332, expiration date: 13-SEP-2015, dose and route were not reported. No adverse reactions were observed or reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history was not reported. On an unknown date these unspecified amount of patients were vaccinated with M-M-R II (lot #, dose and route were not reported), that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported.   Follow up has been received from nurse who stated that the lots numbers involved in the case for M-M-R II was: J016235, expiration date: 19-DEC-2015.  Follow up information was received from the nurse. After temperature excursion vaccines were verified as stable. On 21-AUG-2014 at 16;19, multiple patients were vaccinated with M-M-R II (lot number J016235, expiration date: 19-DEC-2015, dose and route were ot reported. No adverse reactions were observed or reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot #, expiration date, dose unspecified). No adverse symptoms reported. The temperature excursion for ROTATEQ was found to be supported with in-house stability data. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On unkonwn dates the patients were vaccinated with improperly stored GARDASIL (lot #, expiration date, dose and route unspecified). No adverse symptoms reported. The temperature excursion for GARDASIL was found to be supported with in-house stability data. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No medical history was reported. On 29-SEP-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque-forming units) (lot # J003723, expiry: 28-JUN-2014) (route and dose was unknown). On 29-SEP-2014 (also reported as yesterday), the patient may have received an expired ZOSTAVAX. The reporter stated that, the lot number does not seem to match a product according to OMC. No adverse effects were reported. No product quality complaint (PQC) was reported. The outcome of the events was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The patient had no pertinent medical history and drug reactions/allergies. The patient received the first dose of PNEUMOVAX23 (lot#, strength, dose and route unspecified) on an unspecified date in 2012. On 01-OCT-2014 the patient was inadvertently administered with the second dose of PNEUMOVAX23 (lot # K007822, expire date 15-AUG-2014, dose, strength and route unspecified). The patient took no concomitant medication. The patient called the pharmacy on 03-OCT-2014 (also reported as 03-JAN-2014) and stated that her arm around the injection site had been inflamed and red since receipt of the vaccine on 01-OCT-2014.  The patient sought medical attention via calling the pharmacy and the pharmacist stated that she suggested the patient use an ice pack over the area and to use TYLENOL. No lab diagnostics studies were performed. No product quality complaint (PQC) involved. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected as there was no consent to contact they physician.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. Pertinent medical history was unspecified by reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (dose/frequency reported as "1 vaccination", route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The patient visited office and sought medical attention. The outcome of shingles was unknown. The causality was unknown. No further adverse event information was reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patients medical history and current  conditions are not reported. On 05-OCT-2014 the patient was vaccinated with ZOSTAVAX of strength 0.65 ml via subcutaneous route (lot # K008079 and expiry date 03-SEP-2015). Other co-suspects and concomitant medication are not reported. On 05-OCT-2014, the patient experienced injection site swelling, flu-like symptoms, "raised" area at the injection site after receiving the ZOSTAVAX, hot to touch at the injection site and redness around the injection site. Also reported that the patient still has a headache on 06-OCT-2014 (reported as today) which developed yesterday at an unspecified time after receiving the ZOSTAVAX. Reporter states the patient received treatment as he took BENADRYL on an unspecified date for her symptoms. Also stated that the patient went in to the pharmacy on 6-10-2014, and showed the pharmacist. Cancer and overdose was not reported. Product quality complaint was not reported. The outcome of the events is reported as not recovered. Causality is unspecified by the reporter.  Additional information has been requested.