chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.31
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nodule
Clinical narrative: Redness and swelling at injection site. Nodules.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Lethargy, Pyrexia
Clinical narrative: 2 days fever and extreme lethargy alternating with intensity.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Insomnia, Pain, Pain in extremity, Periarthritis
Clinical narrative: Pain day of shot and continued to get worse when moving arm, chronic pain (ongoing) shooting pain. Bad pain at night can't sleep.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Pain day of shot and continued to get worse when moving arm, chronic pain (ongoing) shooting pain. Bad pain at night can't sleep.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Heart rate increased, Hypotension, Injection site erythema
Clinical narrative: Awoke feeling very dizzy - rapid heart rate, low B.P. after several hours in bed, felt better. Pain at site for approx. 1 wk. Large red spot about 6" wide lasting approx 1 mo. Still have some pain and weakness at site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Awoke feeling very dizzy - rapid heart rate, low B.P. after several hours in bed, felt better. Pain at site for approx. 1 wk. Large red spot about 6" wide lasting approx 1 mo. Still have some pain and weakness at site.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Abasia, Areflexia, CSF immunoglobulin increased, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: CSF test normal, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Miller Fisher syndrome
Clinical narrative: Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Ophthalmoplegia, Pain in extremity, Paraesthesia oral
Clinical narrative: Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Guillain-Barre.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection got swollen, red, warm and very painful. Sx lasted 5 day. Pt took Tylenol for comfort, no other tx needed.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HPV9, HEPA, HPV9
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 16-year-old female patient who received HAVRIX pediatric (batch number 93B2D, expiry date 21st November 2017). Concomitant products included GARDASIL and Birth Control. On 1st February 2016, the patient received the 2nd dose of HAVRIX pediatric (intramuscular). On 1st February 2016, 4 hrs after receiving HAVRIX pediatric, the patient experienced hives (serious criteria other: as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to HAVRIX pediatric. Additional details were provided as follows: The nurse reported that a patient developed hives after receiving a HAVRIX and GARDASIL vaccine. The vaccine was administered on 1st February 2016, in the morning at 8.00 and the patient's mother called after lunch the same day. The patient was instructed to take BENADRYL to prevent the spread of hives. The reporter thought that the hives might be worse at the time of reporting, since the family called again and the patient would be seen by the office. The reporter stated that this event was also reported to Merck.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HPV9, HEPA, HPV9
Symptoms: Erythema, Joint swelling, Pruritus, Swelling, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 16-year-old female patient who received HAVRIX pediatric (batch number 93B2D, expiry date 21st November 2017). Concomitant products included GARDASIL and Birth Control. On 1st February 2016, the patient received the 2nd dose of HAVRIX pediatric (intramuscular). On 1st February 2016, 4 hrs after receiving HAVRIX pediatric, the patient experienced hives (serious criteria other: as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to HAVRIX pediatric. Additional details were provided as follows: The nurse reported that a patient developed hives after receiving a HAVRIX and GARDASIL vaccine. The vaccine was administered on 1st February 2016, in the morning at 8.00 and the patient's mother called after lunch the same day. The patient was instructed to take BENADRYL to prevent the spread of hives. The reporter thought that the hives might be worse at the time of reporting, since the family called again and the patient would be seen by the office. The reporter stated that this event was also reported to Merck.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Flushing, Hypertension, Tachycardia
Clinical narrative: Pt reported chest pain, flushed in face, tachycardia, hypertensive, and SOB after receiving Pnuemovax 23 injection. Resolved on own after 20mins.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff syndrome
Clinical narrative: Onset of pain injection, limited range of motion in right shoulder, pain when doing any movement. MRI results show two tears in my roator cuff resulting from the flu shot. Did cortisone shot and still doing 2-3 times a week of Physical therapy.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Chills, Haemoptysis, Headache, Injection site rash, Nausea
Clinical narrative: Pt describes feeling fever, chills, headache, nausea in the hours following Yellow Fever vaccination. Presented to medical provider 3/1/16 w complaint of fever, chills, nausea, productive cough with scant blood. 4.5 x 5 cm rash noted over injection site. Pt prescribed sudafed 30mg, Mucinex dm, Tylenol for symptoms, instruced to increase hydration and rest for 24 hrs, and return for reassessment 3/2/16.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Productive cough, Pyrexia
Clinical narrative: Pt describes feeling fever, chills, headache, nausea in the hours following Yellow Fever vaccination. Presented to medical provider 3/1/16 w complaint of fever, chills, nausea, productive cough with scant blood. 4.5 x 5 cm rash noted over injection site. Pt prescribed sudafed 30mg, Mucinex dm, Tylenol for symptoms, instruced to increase hydration and rest for 24 hrs, and return for reassessment 3/2/16.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: One day after vaccine, patient observed a rash to upper torso lt upper extremities bilat. took a BENADRYL - self administered. Doing fine 2 days after vaccine.
Age: 33.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: "Strain of rotator cuff capsule" - numbness in hand (recurring) - acute pain when raising left arm (continued).
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Abdominal distension, Abdominal pain upper, Crying, Dermatitis, Diarrhoea
Clinical narrative: My child was experiencing severe stomach pains, crying episodes and could not get comfortable. Her feeding habits changed, pulling away from the breast, tugging on my nipples, crying while feeding, scrunching up and stretching out, her stomach was hard and bloated to the touch. Then after much effort, she would expel frothy, foamy, grass green colored diarrhea, high toxic scented diarrhea. Her bottom was red and inflamed. After her stomach was relieved, she would return to my breast for food, however the behavior at the breast would resumes in a vicious cycle. This has been continuous for the past 4 weeks, and has not ended. Prior to this she was eating every 4 hours during the day and sleeping 6-8 hour at night. Now she wants to feed after every bowel movement and this is approx. every 2 hours day and night. She fusses while feeding and after feeding - she does not have more then a 2.5 hour stretch of sleep now, generally she is sleeping about 1/2 hour between feedings and is fussy before and after she goes to sleep. The Dr. said it must run its course, but it has been 5 weeks and counting. I have been providing her with over the counter gas drops and solutions to alleviate the discomfort, and she will go to sleep for about 30 min. once I administer these drops. This is ongoing, and there is not a definitive recovery time based on the Dr. visit and that this is how she is fighting the Rotavirus and it must run its course.
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Discomfort, Erythema, Faeces discoloured, Feeding disorder of infancy or early childhood, Insomnia
Clinical narrative: My child was experiencing severe stomach pains, crying episodes and could not get comfortable. Her feeding habits changed, pulling away from the breast, tugging on my nipples, crying while feeding, scrunching up and stretching out, her stomach was hard and bloated to the touch. Then after much effort, she would expel frothy, foamy, grass green colored diarrhea, high toxic scented diarrhea. Her bottom was red and inflamed. After her stomach was relieved, she would return to my breast for food, however the behavior at the breast would resumes in a vicious cycle. This has been continuous for the past 4 weeks, and has not ended. Prior to this she was eating every 4 hours during the day and sleeping 6-8 hour at night. Now she wants to feed after every bowel movement and this is approx. every 2 hours day and night. She fusses while feeding and after feeding - she does not have more then a 2.5 hour stretch of sleep now, generally she is sleeping about 1/2 hour between feedings and is fussy before and after she goes to sleep. The Dr. said it must run its course, but it has been 5 weeks and counting. I have been providing her with over the counter gas drops and solutions to alleviate the discomfort, and she will go to sleep for about 30 min. once I administer these drops. This is ongoing, and there is not a definitive recovery time based on the Dr. visit and that this is how she is fighting the Rotavirus and it must run its course.
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Irritability
Clinical narrative: My child was experiencing severe stomach pains, crying episodes and could not get comfortable. Her feeding habits changed, pulling away from the breast, tugging on my nipples, crying while feeding, scrunching up and stretching out, her stomach was hard and bloated to the touch. Then after much effort, she would expel frothy, foamy, grass green colored diarrhea, high toxic scented diarrhea. Her bottom was red and inflamed. After her stomach was relieved, she would return to my breast for food, however the behavior at the breast would resumes in a vicious cycle. This has been continuous for the past 4 weeks, and has not ended. Prior to this she was eating every 4 hours during the day and sleeping 6-8 hour at night. Now she wants to feed after every bowel movement and this is approx. every 2 hours day and night. She fusses while feeding and after feeding - she does not have more then a 2.5 hour stretch of sleep now, generally she is sleeping about 1/2 hour between feedings and is fussy before and after she goes to sleep. The Dr. said it must run its course, but it has been 5 weeks and counting. I have been providing her with over the counter gas drops and solutions to alleviate the discomfort, and she will go to sleep for about 30 min. once I administer these drops. This is ongoing, and there is not a definitive recovery time based on the Dr. visit and that this is how she is fighting the Rotavirus and it must run its course.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling to left upper arm per patient.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Night sweats, Urticaria
Clinical narrative: Night sweats, arm has welts.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma annulare, Rash
Clinical narrative: Soon after flu shot, Patient noted to have a "spot" come up on her right shoulder resembling a ringworm. Spot was treated with with antifungal creams x1 month but got bigger. Patient did not complain of itching. New spots noted to come up on patient. Pt taken to her MD's after hours urgent care where she was diagnose with Granuloma Annulare. Pt prescribed steroid cream, which has not helped. Pt has appt with dermatologist this month. At this time, patient has granuloma annulare spots noted to be covering her arms, legs, abdomen, back, buttocks. Pt did not get the "spots" until after receiving the flu shot.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma annulare, Skin discolouration
Clinical narrative: Soon after flu shot, Patient noted to have a "spot" come up on her right shoulder resembling a ringworm. Spot was treated with with antifungal creams x1 month but got bigger. Patient did not complain of itching. New spots noted to come up on patient. Pt taken to her MD's after hours urgent care where she was diagnose with Granuloma Annulare. Pt prescribed steroid cream, which has not helped. Pt has appt with dermatologist this month. At this time, patient has granuloma annulare spots noted to be covering her arms, legs, abdomen, back, buttocks. Pt did not get the "spots" until after receiving the flu shot.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Dysarthria, Facial paresis, General physical health deterioration, Muscular weakness
Clinical narrative: Started noticing muscle weakness in hands and had difficulty buttoning pants. Over the course of several months muscles in both arms and hands continued to weaken. By April 2015, I started having slurred speech and there is weakness in the facial muscles. My condition continues to deteriorate. Up until the tetanus vaccine I was perfectly healthy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling hot, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: Super hot, felt lousy, whole body ached, head congestion, super tired (literally slept all day), left arm where injection was administered was super swollen and red and painful. Felt like this for 2 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Pain, Sinus congestion
Clinical narrative: Super hot, felt lousy, whole body ached, head congestion, super tired (literally slept all day), left arm where injection was administered was super swollen and red and painful. Felt like this for 2 days.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Borrelia test positive, Cognitive disorder, Condition aggravated, Fatigue
Clinical narrative: Symptoms are a significant increase in anxiety, fatigue and cognitive impairment. Our doctor made us aware that the HPV vaccine may have triggered dormant Lyme disease. Now she has full blown Lyme symptoms including neurological/vision problems. The symptoms began right after the vaccine and have been getting progressively worse.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immunology test abnormal, Lyme disease, Nervous system disorder, Visual impairment
Clinical narrative: Symptoms are a significant increase in anxiety, fatigue and cognitive impairment. Our doctor made us aware that the HPV vaccine may have triggered dormant Lyme disease. Now she has full blown Lyme symptoms including neurological/vision problems. The symptoms began right after the vaccine and have been getting progressively worse.
Age: 0.05
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine administered to patient, patient was supposed to get a Hep B, MA grabbed from blue box without double checking and grabbed Kinrix accidentally.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Abnormal behaviour, Cognitive disorder, Immediate post-injection reaction, Injection site swelling, Injection site warmth
Clinical narrative: My sons arm started swelling at injection point immediately after his injections. The site was hot to touch and three times its normal size. He became lethargic. We immediately called the Dr and were instructed to come back with him. She prescribed antibiotics as well as antihistamines and Motrin. We have been dealing with behavioral issues and severe comprehension issues since these shots. Our son was perfectly healthy and developing at a normal rate prior to this event. The Dr. was incredibly rude to us and more concerned about her vaccination rates than properly reporting this event and the well being of our son.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Lethargy
Clinical narrative: My sons arm started swelling at injection point immediately after his injections. The site was hot to touch and three times its normal size. He became lethargic. We immediately called the Dr and were instructed to come back with him. She prescribed antibiotics as well as antihistamines and Motrin. We have been dealing with behavioral issues and severe comprehension issues since these shots. Our son was perfectly healthy and developing at a normal rate prior to this event. The Dr. was incredibly rude to us and more concerned about her vaccination rates than properly reporting this event and the well being of our son.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Erythema, Pruritus, Rash
Clinical narrative: I asked the patient to stay for half an hour after receiving the vaccine to monitor her for a reaction. Ten or fifteen minutes after administering the vaccine, the patient's voice had gotten raspy and her neck was red and rash-like, and she was very itchy. I called an ambulance for her and they took her to the ER.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Diarrhoea, Diet refusal, Frequent bowel movements, Hyperhidrosis, Irritability
Clinical narrative: My son started showing signs of fever, was sweating and irritable. I gave a dose of infants Tylenol at 6:30. He began having diarrhea around 7:00 PM and was screaming in pain for 3 hours after. From 2/26 until 3/1, he refused to eat solids and continued having acidic diarrhea every few hours each day. The fever continued and was recorded at 100.3 around noon Saturday 2/27, and recorder again at 101.7 at 6:00 PM the same day. Tylenol did bring the fever down but has been a continuous dosage every 6-8 hours for his symptoms. I brought him back to the doctors office where he received the vaccines on 3/1 to report the he reaction and was told he had rotavirus, but he was not tested and has been vaccinated for rotavirus.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Pain, Pyrexia, Rotavirus infection, Screaming
Clinical narrative: My son started showing signs of fever, was sweating and irritable. I gave a dose of infants Tylenol at 6:30. He began having diarrhea around 7:00 PM and was screaming in pain for 3 hours after. From 2/26 until 3/1, he refused to eat solids and continued having acidic diarrhea every few hours each day. The fever continued and was recorded at 100.3 around noon Saturday 2/27, and recorder again at 101.7 at 6:00 PM the same day. Tylenol did bring the fever down but has been a continuous dosage every 6-8 hours for his symptoms. I brought him back to the doctors office where he received the vaccines on 3/1 to report the he reaction and was told he had rotavirus, but he was not tested and has been vaccinated for rotavirus.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Screaming
Clinical narrative: Woke up screaming and drawing his legs up for 2 hours.
Age: 20.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Chills, Dizziness, Fatigue, Headache, Loss of consciousness
Clinical narrative: 20 y/o male received Typhoid Vaccine. began to feel ill late afternoon early evening 6PM. Began to feel chills, tired with headache and light headedness. Called a friend to take him to medical was found unconscious at 11:45. Was transported by 911 EMT to local ER. Woke up in route to ER 12:15. Evaluated in ER released at 0430 02FEB2016.
Age: 20.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Malaise
Clinical narrative: 20 y/o male received Typhoid Vaccine. began to feel ill late afternoon early evening 6PM. Began to feel chills, tired with headache and light headedness. Called a friend to take him to medical was found unconscious at 11:45. Was transported by 911 EMT to local ER. Woke up in route to ER 12:15. Evaluated in ER released at 0430 02FEB2016.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthropathy, Immediate post-injection reaction, Joint crepitation, Joint range of motion decreased
Clinical narrative: Immediately felt a pop, pain and bubble sensation in shoulder joint. Within 3 hours I had decreased range of motion and it continued to decrease until I hardly any use of left arm without significant pain.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Immediately felt a pop, pain and bubble sensation in shoulder joint. Within 3 hours I had decreased range of motion and it continued to decrease until I hardly any use of left arm without significant pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: Red, raised, blanching, well-defined patch of urticaria over left deltoid muscle, tender to light palpation. Gradually increased in diameter to 11cm in longest dimension at time of first assessment. Patient given Tylenol 650mg PO x1, loratadine 10mg PO x1.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pallor
Clinical narrative: Red, raised, blanching, well-defined patch of urticaria over left deltoid muscle, tender to light palpation. Gradually increased in diameter to 11cm in longest dimension at time of first assessment. Patient given Tylenol 650mg PO x1, loratadine 10mg PO x1.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Patient felt dizzy and fainted after receiving IPV, TDaP and HBV shots. Father and I supported patient while at the same time, providing ammonia inhalant. Once patient recovered, he felt nauseated and vomited. I applied cold pack to patients neck and offered apple juice. I asked for assistance and patient was transported to Area 3 via wheelchair to lay on the examination bed and to continuously monitor patient and his vital signs.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Pruritus, Swelling
Clinical narrative: Swelling, itching, bruising treated with ice packs, Tylenol, Benadryl.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Amenorrhoea, Anti-Muellerian hormone level, Blood cortisol, Blood follicle stimulating hormone increased, Blood luteinising hormone increased
Clinical narrative: No more menstrual periods, hot flashes several times a day, thirsty, head "feels tingly".
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blood thyroid stimulating hormone decreased, Haemoglobin normal, Hot flush, Oestradiol, Paraesthesia
Clinical narrative: No more menstrual periods, hot flashes several times a day, thirsty, head "feels tingly".
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pregnancy test negative, Thirst, Thyroxine free normal, White blood cell count decreased
Clinical narrative: No more menstrual periods, hot flashes several times a day, thirsty, head "feels tingly".
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient called me today because she noticed a rash on her arm this morning. Not swollen, itchy or getting larger. I gave her Prevnar 1 week ago and she was thinking it could be from vaccine. Has no allergies.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Acute respiratory distress syndrome, Cough, Death, Dialysis, Dyspnoea
Clinical narrative: This spontaneous report has been received from the patient's best friend's wife, referring to a male patient of unknown age. The patient's medical history and concurrent conditions were not provided. On 02-FEB-2016, the patient was vaccinated with PNEUMOVAX 23, (lot #, route, dose and expiration date were not provided). Concomitant therapies were not reported. On 10-FEB-2016, the patient became ill developing trouble breathing, coughing, and laryngitis. On an unknown date in February 2016, the patient was admitted to the hospital for acute respiratory distress syndrome (ARDS). The patient also developed respiratory failure and renal failure, and the patient was treated with dialysis. The patient also was being treated for pneumonia. The onset date of the events was reported as 10-FEB-2016. On 17-FEB-2016, the patient died, the cause of death was reported as pneumonia related issues. The outcome of laryngitis, and renal failure, was unknown. Upon internal review renal failure, acute respiratory distress syndrome and respiratory failure were considered to be medically significant events. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Laryngitis, Pneumonia, Renal failure, Respiratory failure
Clinical narrative: This spontaneous report has been received from the patient's best friend's wife, referring to a male patient of unknown age. The patient's medical history and concurrent conditions were not provided. On 02-FEB-2016, the patient was vaccinated with PNEUMOVAX 23, (lot #, route, dose and expiration date were not provided). Concomitant therapies were not reported. On 10-FEB-2016, the patient became ill developing trouble breathing, coughing, and laryngitis. On an unknown date in February 2016, the patient was admitted to the hospital for acute respiratory distress syndrome (ARDS). The patient also developed respiratory failure and renal failure, and the patient was treated with dialysis. The patient also was being treated for pneumonia. The onset date of the events was reported as 10-FEB-2016. On 17-FEB-2016, the patient died, the cause of death was reported as pneumonia related issues. The outcome of laryngitis, and renal failure, was unknown. Upon internal review renal failure, acute respiratory distress syndrome and respiratory failure were considered to be medically significant events. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Erythema
Clinical narrative: Started as a pin size red area and progressed to a 4 cm x 4 cm as of 3/1/16.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On multiple unspecified dates the patients received doses of improperly stored GARDASIL 9 (lot#/expiration date, dose and route were unspecified). The reporter stated that the thermometer temperatures were out of correct storage range (low of 30.2 F and high of 50 F) for an unknown time frame. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous case report was received from a physician via company representative regarding 1-2 (unspecified) patients of unknown age and unknown gender. No concurrent conditions and medical history of these patients were reported. On an unknown date, these patients were vaccinated with GARDASIL, 0.5 ml . No concurrent conditions and medical history of these patients were reported. On an unknown date, these patients were vaccinated with GARDASIL, 0.5 ml. No concomitant medications of the patients were reported. On an unknown date following vaccination with GARDASIL, these patient's experienced syncope/syncopal episodes. The outcome of the event was unknown. The relatedness of the event syncope with the suspect product GARDASIL was unknown. No product quality complaint was reported. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 15-OCT-2015, the patent was vaccinated with a dose of improperly stored M-M-R II lot # J016232, (dose, strength, route of administration and expiry date were not reported). No adverse events were reported. The reason for the temperature excursion was because daily vaccine counts cause the storage unit to have temperature fluctuations because of the door opening. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence has been received.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. On 12-MAY-2015, the patient received a first dose of VAQTA 0.5 mg (route and site of administration, lot number and expiration date were not reported), then the same patient received a second dose of VAQTA 0.5 mg, lot# L007559, exp. 01-JUN-2017 on 18-AUG-2015 and then the same patient received a third dose of VAQTA 0.5 mg, lot# L036300, expiration date 04-NOV-2016, 0.5 mg, on 22-DEC-2015. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (dose, strength, route of administration and expiry date were not reported) lot # reported as K010211. On the same day, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # K010211, (dose, strength, route of administration and expiry date were not reported). No adverse events were reported. The reason for the temperature excursion was because daily vaccine counts cause the storage unit to have temperature fluctuations because of door opening. Lot # K01011 has been verified as non-valid lot # for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence has been received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# reported as K010211, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. Lot# K010211 is an invalid lot number for MMR II, however is valid for (Oka-Merck) PROQUAD. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare professional (reported as health worker) referring to a patient of unknown age and gender. On 26-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route were unknown, lot # K021624, expiry date: 07-FEB-2016). No known adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dyspnoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer referring to her daughter, a 12 year old female patient with retinoblastoma, a tribulated bladder and migraines. The patient was a cancer (uncertain type) survivor and had no drug reaction/allergies. The patient was vaccinated with three doses of GARDASIL 9 (0.5 ml, route and lot# were unknown) on 24-JUL-2015, 03-DEC-2015 and 24-FEB-2016, respectively (inappropriate schedule of drug administration). Concomitant medication included amitriptyline hydrochloride (manufacturer unknown). Later after the third dose administration, on 24-FEB-2016, the patient experienced dizziness and shortness of breath. The patient called to a physician's office for medical attention. No treatment was given to the patient and no lab was performed. The patient recovered from dizziness and shortness of breath on 24-FEB-2016. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Testicular pain, Testicular swelling
Clinical narrative: Information has been received from a physician via a company representative referring to a male patient of unknown age. On an unknown date the patient was vaccinated with his first dose of GARDASIL 9 (dose, lot # and route were unknown). On an unknown date, one week post administration of the first dose, the patient experienced multiple episodes of testicular swelling and pain. The patient was sent to an unspecified emergency department as advised by reporting physician where a computerized axial tomography scan (CAT scan) was performed to rule out testicular torsion. The reporting physician stated the results of the CAT scan were negative for testicular torsion and there were no anatomical abnormalities. There was no treatment given for the events. The event of testicular swelling was resolved on its own. The outcome of testicular pain was reported as recovering. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient who was 50 or 60 years old. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unspecified date in 2015 (reported as sometime last year) the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (strength, dose#, lot# and route unknown, frequency was reported as once). Five days later (unknown date in 2015) the patient broke out with shingles. Lab diagnostics studies were not performed. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in January 2016, the patients were vaccinated with improperly stored dose (temperature: 33.7 F, time frame: 1 hour) of GARDASIL (lot # K010215, exp. 05-MAY-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
Age: 1.79
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 21 month old patient of unknown gender. On 24-FEB-2016 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX that was improperly stored (dose and route were not reported). It was not specified the lot # was L034370 (expiration date 08-SEP-2017) or L013063 (expiration date 14-APR-2017). The vaccine was exposed to temperature max -4 degree for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Lip swelling, Swelling face
Clinical narrative: Information has been received from a registered nurse referring to a 76 year old male patient with allergy to mercury. The patient was a nursing home patient. The patient was administered one dose of PREVNAR 13 and unspecified flu shot on an unspecified date (reported as a few months ago). The patient was administered a dose of PNEUMOVAX 23 (dose, route and lot# not reported) in 2013. On 17-FEB--2016 the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route and lot# not reported) for vaccination. Concomitant therapy was not reported. It was reported that as of early 19-FEB-2016, the night nursing staff noticed this patient's face and lip to be swollen, the patient was treated with BENADRYL and prednisone. The reporter noted that when she assessed the patient the morning of 19-FEB-2016, the patient clearly had a different facial expression. At the time of reporting, the outcome of the patient was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in October 2015, the patients were vaccinated with improperly stored dose (temperature: 49 F, time frame: 1 hour) of MMR II (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in October in 2015, the patients were vaccinated with improperly stored dose of PROQUAD (Merck) (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in October 2015, the patients were vaccinated with improperly stored dose (temperature: 11.7 F, time frame: 1 hour) of VARIVAX (Merck) (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in January 2016, the patients were vaccinated with improperly stored dose (temperature: 49 F, time frame: 1 hour) of ROTATEQ (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in October 2015, the patients were vaccinated with improperly stored dose of GARDASIL (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in January 2016, the patients were vaccinated with improperly stored dose (temperature: 33.7 F, time frame: 1 hour) of ROTATEQ (lot # L037921, exp. 31-MAY-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified adult patient of unknown age. On 25-FEB-2016 the patient was vaccinated with a dose of expired RECOMBIVAX HB (lot # J008505; expiry: 07-FEB-2016) (dosing regimen unspecified). No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Occupational exposure to product
Clinical narrative: This spontaneous report was received from a 41 year old female pharmacist of unknown age and who was reporting on herself. The patient was not pregnant and did not have any drug reactions or allergies nor concomitant medications. The patient had a history of being immunocompromised due to an unspecified reason. The pharmacist reported that she administered ZOSTAVAX (multiple unspecified lots and expiration dates) to multiple unspecified patients in an occupational contact setting on multiple dates (exact dates were not reported). On an unspecified dates in 2015 (reported as this past year on unspecified dates), the patient had two active cases of shingles that were diagnosed by her primary care physician. The patient was advised by her rheumatologist "not to have occupational contact with ZOSTAVAX" and she has been "administering ZOSTAVAX to multiple unspecified patients over the past year". There was no lab diagnostics and studies performed. The outcome of the shingles was recovered/resolved (on an unspecified date). The pharmacist felt that it might be a possibility that she may have had shingles due to the occupational contact with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA lot # L036300, expiration date 04-NOV-2016 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a pharmacy intern, referring to a female patient of an unknown age. The patient's pertinent medical history, drug reaction or allergies were not reported. On 30-JAN-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU lot # L032402, expiration date 26-NOV-2016 (dose, route of administration and anatomical location were not reported). Concomitant medications were unknown. On 16-FEB-2016, the patient submitted a prescription for MEDROL dose pack, doxycycline (manufacturer unknown) and an unspecified cough syrup. On 19-FEB-2016, the prescription was submitted to the patient. The health care student did not know why the patient received these prescriptions and she stated the following: "she must has been sick" (Malaise) (onset date in 2016). At the time of this report, the outcome of malaise was unknown. The reporter stated that vaccination with ZOSTAVAX and the patient's illness (malaise) was not related. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L010144, expiry date 24-MAR-2017 and lot # L026410, expiry date 15-FEB-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was noted at 15.8 Fahrenheit for 37 hours and 51 minutes, there was no previous temperature excursion. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from the patient's wife and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a second dose of PNEUMOVAX 23 (lot #, dose and route were not provided). No adverse effect was reported. Additional information is not expected, as no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patient of unknown age and gender. On unknown dates, the patient were vaccinated with doses of improperly stored GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017, lot # L043213, expiration date 20-AUG-2017) (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.