chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Painful respiration, Paraesthesia, Pyrexia, Retching, Skin warm
Clinical narrative: Pain at injection site first 5 hours following injection but no redness. Really bad headache and body aches developed first during later afternoon (4pm). By 5pm terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply, low grade fever. Nurse was called and ibuprofen given. Symptoms worsened over course of the night. Progressed to higher fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen) horrible joint pain and dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (and she never cries). Better by morning but still had headache and body aches. Today, third day out, better but exhausted and has body aches and headache still. Symptoms worsen when she is fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches return). Not sure if I'm remembering all of them, but this is as accurate as I can remember.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Arthralgia, Body temperature increased, Crying, Injection site pain
Clinical narrative: Pain at injection site first 5 hours following injection but no redness. Really bad headache and body aches developed first during later afternoon (4pm). By 5pm terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply, low grade fever. Nurse was called and ibuprofen given. Symptoms worsened over course of the night. Progressed to higher fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen) horrible joint pain and dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (and she never cries). Better by morning but still had headache and body aches. Today, third day out, better but exhausted and has body aches and headache still. Symptoms worsen when she is fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches return). Not sure if I'm remembering all of them, but this is as accurate as I can remember.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity
Clinical narrative: Pain at injection site first 5 hours following injection but no redness. Really bad headache and body aches developed first during later afternoon (4pm). By 5pm terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply, low grade fever. Nurse was called and ibuprofen given. Symptoms worsened over course of the night. Progressed to higher fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen) horrible joint pain and dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (and she never cries). Better by morning but still had headache and body aches. Today, third day out, better but exhausted and has body aches and headache still. Symptoms worsen when she is fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches return). Not sure if I'm remembering all of them, but this is as accurate as I can remember.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site mass, Pyrexia, Vomiting
Clinical narrative: Large lump at site of injection, redness that spread, fever up to 102.9, vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Pyrexia
Clinical narrative: Headache--two-and-a-half days; diarrhea, abdominal discomfort--a few hours; fever--one day (100.5 degrees).
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Large red swollen area. Pt reports it was originally from shoulder to elbow. After taking antihistamines and applying ice area is now much smaller but significantly red.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Burning sensation, Injection site bruising, Injection site swelling, Rash, Skin warm
Clinical narrative: 07/16/15 - 4:00pm burning rash warm to touch on left arm looked like bruise at injection site swollen. Urgent care doctor prescribed AUGMENTIN, naproxen and prednisone 2.5.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to multiple unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a health professional (nurse) refers to multiple unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unspecified date, the patients were vaccinated with improperly stored M-M-R II (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to multiple unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unspecified date, the patients were vaccinated with improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the four reports received from the same reporter. 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 health professional (nurse) refers to multiple unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ. Concomitant medications were not reported. No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Decreased appetite, Feeling cold, Laboratory test, Myalgia
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report # 2015131602 concerning a currently 72 year old male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported). On an unknown date, the patient experienced chills, rash, loss of appetite, joint pain, muscle aches and fever. At the time of the report, the patient's outcome was unknown. This was originally reported by a physician. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report # 2015131602 concerning a currently 72 year old male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported). On an unknown date, the patient experienced chills, rash, loss of appetite, joint pain, muscle aches and fever. At the time of the report, the patient's outcome was unknown. This was originally reported by a physician. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report # 2015131602 concerning a currently 72 year old male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported). On an unknown date, the patient experienced chills, rash, loss of appetite, joint pain, muscle aches and fever. At the time of the report, the patient's outcome was unknown. This was originally reported by a physician. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report # 2015131602 concerning a currently 72 year old male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported). On an unknown date, the patient experienced chills, rash, loss of appetite, joint pain, muscle aches and fever. At the time of the report, the patient's outcome was unknown. This was originally reported by a physician. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Arthralgia, Back pain, Crying, Fatigue
Clinical narrative: HPV 9 given 7/17/15. Sun 7/18/15 last night got a lot of arm pain at the site of the shot, then went to joint pain in elbow/knees/hips. Was crying about how bad it hurt, including abnormal cramps like period, had temp. 99-100 degrees. Mom gave her ibuprofen and TYLENOL but did not help. Slept finally at 6 AM until now and feels better. No symptoms now except sore arm.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Headache, Hyperaesthesia, Injection site pain, Nausea, Pain
Clinical narrative: HPV 9 given 7/17/15. Sun 7/18/15 last night got a lot of arm pain at the site of the shot, then went to joint pain in elbow/knees/hips. Was crying about how bad it hurt, including abnormal cramps like period, had temp. 99-100 degrees. Mom gave her ibuprofen and TYLENOL but did not help. Slept finally at 6 AM until now and feels better. No symptoms now except sore arm.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Painful respiration, Paraesthesia, Pyrexia, Retching, Skin warm
Clinical narrative: HPV 9 given 7/17/15. Sun 7/18/15 last night got a lot of arm pain at the site of the shot, then went to joint pain in elbow/knees/hips. Was crying about how bad it hurt, including abnormal cramps like period, had temp. 99-100 degrees. Mom gave her ibuprofen and TYLENOL but did not help. Slept finally at 6 AM until now and feels better. No symptoms now except sore arm.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Arthralgia, Body temperature increased, Crying, Injection site pain
Clinical narrative: HPV 9 given 7/17/15. Sun 7/18/15 last night got a lot of arm pain at the site of the shot, then went to joint pain in elbow/knees/hips. Was crying about how bad it hurt, including abnormal cramps like period, had temp. 99-100 degrees. Mom gave her ibuprofen and TYLENOL but did not help. Slept finally at 6 AM until now and feels better. No symptoms now except sore arm.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity
Clinical narrative: HPV 9 given 7/17/15. Sun 7/18/15 last night got a lot of arm pain at the site of the shot, then went to joint pain in elbow/knees/hips. Was crying about how bad it hurt, including abnormal cramps like period, had temp. 99-100 degrees. Mom gave her ibuprofen and TYLENOL but did not help. Slept finally at 6 AM until now and feels better. No symptoms now except sore arm.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: My arm was so sore that I could not move it.  I took two (2) Extra Strength Tylenol.  On 5/23/15, I developed a fever of 100.6 which is unusual because I never develop a fever.  It is now 7/20/15--almost two months later--and my arm is still sore and I cannot raise it towards my back or criss-cross my arms to remove a shirt.  I have to use my right arm to lift my sore left arm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Gait disturbance, Guillain-Barre syndrome, Insomnia, Lumbar puncture abnormal
Clinical narrative: Please tell your story.: On May 13, 2015, my husband recieved a Prevnar 13 vaccination shot. (Pfizer Prevnar 13 lot # L62072 / ex: 11/06/16 NDC # 0005-1971-02. My husband's symptoms started on 22 May 2015 with extreme pain in the pelvis and legs making sleep nearly impossible. On the morning of May 27th my husband thought he was having or had a stroke with the left side of his face drooping. We rushed to our 1st ER visit - May 27, 2015 where a diagnosis of Bells Palsy was made. Prednisone was prescribed for the Bells Palsy. On the following day we rushed back to the emergency room May 28, 2015, the paralysis had taken over the entire face - diagnosis Bells Palsy both sides. He told the doctors about pain yet they focused on facial issues and didn't seem concerned about the pain. The pain and sleeplessness continued. Then during the day of the 30th, the lower paralysis started setting in with unsteadiness progressing to staggering. By 3am the lower body paralysis was well established requiring a walker. We returned to the ER June 1st 4:30am! He was admitted that day and was given a spinal puncture with the diagnosis 1 hour later of Guillain Barre Syndrome, Miller Fisher Syndrome varient. Fortunately the GBS did not effect his respiratory or swallowing. My husband spent the next 8 days in the Neuro unit undergoing 6 plasma pheresis treatments and at all times was heaviliy medicated for extreme pain. On June 8, 2015 he progressed to the point where he was moved to the inhouse rehab center at the Hospital. At this point the focus was for PT, OT, and Speech therapy. He came home June 24, 2015 and is learning to walk and has a lot of recuperating with a full recovery in 6 months.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Miller Fisher syndrome, Pain in extremity, Paralysis, Pelvic pain, Plasmapheresis
Clinical narrative: Please tell your story.: On May 13, 2015, my husband recieved a Prevnar 13 vaccination shot. (Pfizer Prevnar 13 lot # L62072 / ex: 11/06/16 NDC # 0005-1971-02. My husband's symptoms started on 22 May 2015 with extreme pain in the pelvis and legs making sleep nearly impossible. On the morning of May 27th my husband thought he was having or had a stroke with the left side of his face drooping. We rushed to our 1st ER visit - May 27, 2015 where a diagnosis of Bells Palsy was made. Prednisone was prescribed for the Bells Palsy. On the following day we rushed back to the emergency room May 28, 2015, the paralysis had taken over the entire face - diagnosis Bells Palsy both sides. He told the doctors about pain yet they focused on facial issues and didn't seem concerned about the pain. The pain and sleeplessness continued. Then during the day of the 30th, the lower paralysis started setting in with unsteadiness progressing to staggering. By 3am the lower body paralysis was well established requiring a walker. We returned to the ER June 1st 4:30am! He was admitted that day and was given a spinal puncture with the diagnosis 1 hour later of Guillain Barre Syndrome, Miller Fisher Syndrome varient. Fortunately the GBS did not effect his respiratory or swallowing. My husband spent the next 8 days in the Neuro unit undergoing 6 plasma pheresis treatments and at all times was heaviliy medicated for extreme pain. On June 8, 2015 he progressed to the point where he was moved to the inhouse rehab center at the Hospital. At this point the focus was for PT, OT, and Speech therapy. He came home June 24, 2015 and is learning to walk and has a lot of recuperating with a full recovery in 6 months.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: VIIth nerve paralysis, Walking aid user
Clinical narrative: Please tell your story.: On May 13, 2015, my husband recieved a Prevnar 13 vaccination shot. (Pfizer Prevnar 13 lot # L62072 / ex: 11/06/16 NDC # 0005-1971-02. My husband's symptoms started on 22 May 2015 with extreme pain in the pelvis and legs making sleep nearly impossible. On the morning of May 27th my husband thought he was having or had a stroke with the left side of his face drooping. We rushed to our 1st ER visit - May 27, 2015 where a diagnosis of Bells Palsy was made. Prednisone was prescribed for the Bells Palsy. On the following day we rushed back to the emergency room May 28, 2015, the paralysis had taken over the entire face - diagnosis Bells Palsy both sides. He told the doctors about pain yet they focused on facial issues and didn't seem concerned about the pain. The pain and sleeplessness continued. Then during the day of the 30th, the lower paralysis started setting in with unsteadiness progressing to staggering. By 3am the lower body paralysis was well established requiring a walker. We returned to the ER June 1st 4:30am! He was admitted that day and was given a spinal puncture with the diagnosis 1 hour later of Guillain Barre Syndrome, Miller Fisher Syndrome varient. Fortunately the GBS did not effect his respiratory or swallowing. My husband spent the next 8 days in the Neuro unit undergoing 6 plasma pheresis treatments and at all times was heaviliy medicated for extreme pain. On June 8, 2015 he progressed to the point where he was moved to the inhouse rehab center at the Hospital. At this point the focus was for PT, OT, and Speech therapy. He came home June 24, 2015 and is learning to walk and has a lot of recuperating with a full recovery in 6 months.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram normal, Injection site pain, Injection site swelling, Injection site warmth, Lumbar puncture
Clinical narrative: Pain and warmth/swelling at the site. Migraine headache. Required 2 ER visits 7/11/15 & 7/13/15 with medical treatment (phenergan, decadron, morphine, Vicodin, Percocet, NS bolus, Reglan) received prescription for Flexeril and Fioricet.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine
Clinical narrative: Pain and warmth/swelling at the site. Migraine headache. Required 2 ER visits 7/11/15 & 7/13/15 with medical treatment (phenergan, decadron, morphine, Vicodin, Percocet, NS bolus, Reglan) received prescription for Flexeril and Fioricet.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain at injection site, redness and swelling to injection site, fever 102, headache, swelling at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient's mother finally produced a previous immunization record for patient and that is when we realized we did not have to administer the shots today.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Generalized achiness, sniffles, headache, insomnia.  Area around injection is reddened, hot, tender and firm to touch.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Insomnia, Pain, Rhinorrhoea
Clinical narrative: Generalized achiness, sniffles, headache, insomnia.  Area around injection is reddened, hot, tender and firm to touch.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site swelling, Pallor
Clinical narrative: On July 17, 2015, client received the MCV4 vaccine at 1146.  Client tolerated well, denied complaints, left clinic without difficulty.  Client returned to immunization clinic waiting room with mother at 1153.  Client was pale and stated she felt lightheaded.  RN had client lay down on floor, patient immediately became less pale.  No other distress noted.  Client remained conscious.  Client states the only food she had eaten was a package of peanut butter crackers on the way to the clinic.  Client remained in the clinic for 30 minutes, during which time she drank a Sprite.  Client was able to stand and walk without difficulty or feeling lightheaded prior to leaving clinic.  RN walked with client out to mom's personal vehicle at 1223.  Client was buckled in and denied complaint.  RN discussed with client's mother to get client food to eat and to seek medical attention and notify the health department of any further or worsening problems. RN called mother on July 20, 2015 at 0940 to follow up with patient.  Mother states patient is currently experiencing no problems.  She states client's arm was slightly reddened and swollen at the injection site throughout the weekend, but that the problem has resolved.  She states client was tired and rested on Friday.  Client's mother also states that she "didn't think about it at the time, but now I remember patient threw up on the nurse after she got this vaccine [MCV4] the last time."  RN advised mother that she and/or client should be sure future healthcare and immunization providers are aware of the occurrences following MCV4 vaccination.  Note made in client's profile regarding occurrence.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pyrexia
Clinical narrative: Fever, edema in right arm, and inability to move right arm.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Neck pain, Pain
Clinical narrative: Neck pain, headache and sensitivity when moving head. Symptoms happened within 3-4 hours of vaccine.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash lasted for 4-5 weeks and was in face, arms, legs and head also itchy treated with topical steroid.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever 104. Seizures.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dermatitis contact, Rash generalised
Clinical narrative: Rash noted on the face and neck around 3:00 PM 7-7-15, moving to arms and legs. Urgent care visit 7-7-15 for rash. Dx contact dermatitis. Rash faded and patient had no other symptoms.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: S/S redness, swelling, heat, pain at injection site (R) deltoid. Plan: Ibuprofen, warm moist compresses, BENADRYL (or ZYRTEC), anti-itch cream RTC Friday if no better sooner if worsens.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient experiencing extreme arm pain with limited arm mobility 1 week after vaccination.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Erythema, Lethargy, Pain, Tenderness
Clinical narrative: Vaccination 6/5/15 (R) arm; 6/7/15 sore to touch, 6/10 pain and tenderness worse, weak, lethargic; just laid around with ice pack, 6/12 gradually getting better but 4 x 8 inches redness.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Redness/swelling from 7/10/15-7/11/15 went to walk in. BENADRYL 12.5mg Q 6 hours PRN et ORAPRED 15mg/5ml 1 tsp dly x 5 days.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to multiple patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 03-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to 10 patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the 10 patients were vaccinated with improperly stored VARIVAX (strength, route unspecified) lot # L001327, expiration date 13-JAN-2017. No adverse symptoms reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1507USA008508, 1507USA004977 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Dysphagia, Lip swelling, Nausea, Vomiting
Clinical narrative: Information has been received from a register nurse referring to a patient of unknown age. On 25-JUN-2015, the patient was vaccinated with RECOMBIVAX HB, (dose, route and lot number not provided). On 25-JUN-2015, the patient developed swollen lips shortly afterwards receiving the vaccine. The nurse reported that within 1 week the patient developed difficulty swallowing, the lip swelling had resolved. The outcome of vomiting and nausea was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB which were exposed to 1.0 C for 5 hours, (Dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored, oral, ROTATEQ which were exposed to 1.0 C for 5 hours (Dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 63 year old female patient. Information regarding the patient's medical history or concurrent conditions was not provided. On 06-JUL-2015, the patient was vaccinated with ZOSTAVAX subcutaneous injection, lot # L008357 with expiration date of: 11-JUN-2016, 0.65 ml, subcutaneous. Concomitant therapy was not reported. On 09-JUL-2015, the patient developed a rash on an unspecified area of the body, following the administration of ZOSTAVAX. Then, on 13-JUL-2015, the patient was seen by an unspecified physician who diagnosed her with shingles and prescribed her treatment with: amoxicillin 500mg 3 times daily for 7 days, Prednisone (manufacturer unknown) 60 mg for 3 days, 40 mg for 3 days, and 20mg for 3 days; acyclovir tablets 1gm 3 times daily for 1 week, and Miconazole 0.1% cream 2 times daily. At the time of this report, the outcome of herpes zoster was unknown. 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 nurse refers to a 10 unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA (lot # K019560 and expiry date: 02-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was reported for VAQTA. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with a dose of an improperly stored PNEUMOMVAX 23 (dose, frequency and lot# were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an approximately (currently) 22 year old male patient. There was no information about concomitant medication, pertinent medical history and drug reaction, allergies reported. On unknown date, as a child, the patient was vaccinated with a 3-dose series of RECOMBIVAX HB (lot#s, expiration dates, doses, frequency, routes and sites of vaccination were not reported) for routine vaccination. On an unspecified date in approximately 2015, reported as "recently", the patient had the titers drawn, which showed the hepatitis B titers were too low. There was no product quality complaint (PQC) involved. The outcome of the event was unknown. The patient sought medical attention and was seen by a physician. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Drug interaction, Erythema, Herpes simplex, Inflammation
Clinical narrative: Rash to left arm, red with white ring around the red area of inflammation-urticarial, warm to the touch. 9x11cm, tenderness, blisters to corners to mouth (representative of herpes simplex 1 outbreak). Tx: Prednisone-taper dose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Rash, Skin warm, Tenderness, Urticaria
Clinical narrative: Rash to left arm, red with white ring around the red area of inflammation-urticarial, warm to the touch. 9x11cm, tenderness, blisters to corners to mouth (representative of herpes simplex 1 outbreak). Tx: Prednisone-taper dose.
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Measles antibody negative, Mumps antibody test negative, Pharyngitis, Rhinitis
Clinical narrative: This spontaneous report was received from a female patient of unknown age who is also a physician referring to herself. The patient did not have pertinent medical history and not drug reactions or allergies. The physician reported that she received an unspecified number of doses of unspecified MMR II (manufacturer unknown) vaccines for prophylaxis on an unspecified dates in 1977 and 1978, and due too poor quality documentation in her medical records, the physician was uncertain whether she received separate doses of ATTENUVAX, MERUVAX II and MUMPSVAX (strength, doses, frequencies, routes, anatomical locations, lot numbers and expiration dates were not reported), or whether she received doses of MMR or MMR II (strength, doses, frequencies, routes, anatomical locations, lot number and expiration dates were not reported). The physician did not have her medical records and was required to have titers drawn on an unspecified date in May 2015, which showed that her titers were "too low" and therefore negative for immunity to MMR II. As as result, the physician was then administered a dose of MMR II (strength, doses, frequencies, routes, anatomical locations, lot numbers and expiration dates were not reported). There was not concomitant medication. Subsequently, on an unknown date in 2015, 12 to 14 days after she received the dose of MMR II, she experienced severe pharyngitis, rhinitis and conjunctivitis which progressed to sinusitis. The patient sought medical attention on an unknown date through visited her physician and was prescribed AUGMENTIN (strength, dose, frequency and route were not reported). On the other hand, on an unspecified date in June 2015, the physician's titters were re-drawn, which showed she was immune to mumps and rubella, but not to measles described as "0.2 away from being immune". The outcome of measles antibody negative was not recovered/not resolved. The outcome of mumps antibody test negative and rubella antibody negative was recovered/resolved on an unspecified date in June 2015. The outcome of pharyngitis, rhinitis and conjunctivitis was unknown. The reporter considered conjunctivitis, rhinitis, pharyngitis and sinusitis to be not related to MUMPSVAX, MMR, MERUVAX II and ATTENUVAX. The relatedness between measles antibody negative, mumps antibody test negative and rubella antibody negative and therapy with MMR II, MUMPSVAX, MMR, MERUVAX II and ATTENUVAX was not reported. Additional information is not expected because the reported wanted to remain anonymous and her contact details were not provided.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative, Sinusitis
Clinical narrative: This spontaneous report was received from a female patient of unknown age who is also a physician referring to herself. The patient did not have pertinent medical history and not drug reactions or allergies. The physician reported that she received an unspecified number of doses of unspecified MMR II (manufacturer unknown) vaccines for prophylaxis on an unspecified dates in 1977 and 1978, and due too poor quality documentation in her medical records, the physician was uncertain whether she received separate doses of ATTENUVAX, MERUVAX II and MUMPSVAX (strength, doses, frequencies, routes, anatomical locations, lot numbers and expiration dates were not reported), or whether she received doses of MMR or MMR II (strength, doses, frequencies, routes, anatomical locations, lot number and expiration dates were not reported). The physician did not have her medical records and was required to have titers drawn on an unspecified date in May 2015, which showed that her titers were "too low" and therefore negative for immunity to MMR II. As as result, the physician was then administered a dose of MMR II (strength, doses, frequencies, routes, anatomical locations, lot numbers and expiration dates were not reported). There was not concomitant medication. Subsequently, on an unknown date in 2015, 12 to 14 days after she received the dose of MMR II, she experienced severe pharyngitis, rhinitis and conjunctivitis which progressed to sinusitis. The patient sought medical attention on an unknown date through visited her physician and was prescribed AUGMENTIN (strength, dose, frequency and route were not reported). On the other hand, on an unspecified date in June 2015, the physician's titters were re-drawn, which showed she was immune to mumps and rubella, but not to measles described as "0.2 away from being immune". The outcome of measles antibody negative was not recovered/not resolved. The outcome of mumps antibody test negative and rubella antibody negative was recovered/resolved on an unspecified date in June 2015. The outcome of pharyngitis, rhinitis and conjunctivitis was unknown. The reporter considered conjunctivitis, rhinitis, pharyngitis and sinusitis to be not related to MUMPSVAX, MMR, MERUVAX II and ATTENUVAX. The relatedness between measles antibody negative, mumps antibody test negative and rubella antibody negative and therapy with MMR II, MUMPSVAX, MMR, MERUVAX II and ATTENUVAX was not reported. Additional information is not expected because the reported wanted to remain anonymous and her contact details were not provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-APR-2015, the patient was vaccinated with a dose of GARDASIL lot # k006960 (expiration date, dose, route and site of administrations were not provided) that was exposed to temperatures outside of the recommended range for 63 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Pain, swelling, warm to touch, with red blotches extending down arm 6-7 inches from injection site.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: Low grade fever, redness at vaccine site, bodyaches, fatigue. All symptoms lasted 3 days. Vaccine site still has redness and light swelling when patient was seen 4 days after vaccine administered.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Pyrexia, Skin warm, Urine analysis normal, Vaccination complication
Clinical narrative: Around 7:00 PM I noticed that my daughter had a fever so I took her temperature and it was 101.3 and I thought it was normal. She went to bed and around 11:00 PM I woke her up to eat because she had skipped a feeding and she was very, very warm. I took her temperature again and it was 103.5. I called the ON-CALL line at her Pediatrician office and I was told that she was fine, just to administer Motrin and Tylenol.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported 2 cases. This is 2 of 2 cases. A 55-year-old male patient received PREVNAR 13 (Lot # L62074, Expiry Date Nov2016, NDC# 00005197102) subcutaneous at 0.5 ml, single on 26Jun2015. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis of the left arm on 30Jun2015 and fever of 100.4 on 27Jun2015. The outcome of the events was unknown. Patient was admitted to the hospital for 2 nights with cellulitis of the left arm. He was given antibiotics during his hospital stay. The patient was also hospitalized for fever from 30Jun2015 to an unknown date. Hospital discharge date was unknown. The relatedness of drug to event Cellulitis was unknown.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Intensive care, Night sweats, Pneumonia, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 51-year-old male patient received, on an unknown date (on 01Jul of an unspecified year), PREVNAR 13 single dose. The patient was without spleen. Concomitant medications were unknown. On an unspecified date, he experienced high fever and night sweats. On 05Jul (of an unspecified year), the patient was admitted to the hospital and placed in the intensive care unit (ICU). He received his last pneumonia shot 10 years ago. The hospital doctors stated that he had pneumonia. Clinical outcome of the events was unknown at time of this report.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Hyperhidrosis, Loss of consciousness, Nervousness, Pallor
Clinical narrative: About 6-7 minutes after pt was given PREVNAR-13, pt was being instructed on how to use glucometer when she became very anxious, shaky, pale and diaphoretic. Pulse O2 was placed which registered oximetry of 89% and pulse of 30. Pt then lost consiousness and no pulse registered on pulse O2. Pt was unconscious for 1-2 minute with a weak thready pulse. EMS was called. Pt did regain consciousness and transferred to ER.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pulse abnormal
Clinical narrative: About 6-7 minutes after pt was given PREVNAR-13, pt was being instructed on how to use glucometer when she became very anxious, shaky, pale and diaphoretic. Pulse O2 was placed which registered oximetry of 89% and pulse of 30. Pt then lost consiousness and no pulse registered on pulse O2. Pt was unconscious for 1-2 minute with a weak thready pulse. EMS was called. Pt did regain consciousness and transferred to ER.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Hot flush, Lethargy, Myalgia, Nausea
Clinical narrative: Chills, Hot Flashes, Nausea, Muscle Pain, Extreme Lethargy for 6 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Large localized reaction > 10 cm, erythema, no discharge on rt lat thigh/injection site.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with a dose of MMR II (HSA, lot # J005846, expiration date 13-APR-2015, dose and route not reported), which was improperly stored. No concomitant therapy was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with improperly stored PROQUAD (Merck) (dose strength, route unspecified) lot # L003221, expiration date 30-JUL-2016. No adverse symptoms reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1507USA008507, 1507USA008508 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a certified medical assistant referring to 20 patients of unknown age. On unspecified dates, these patients were inadvertently administered improperly stored (Oka/Merck) VARIVAX (Strength: 1350 U, Lot# L001326, Expiration date 13-JAN-2017) subcutaneously (dose unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 29-JUN-2015 was vaccinated with a dose of ROTATEQ (lot # K016313, expiration date was not reported) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a licensed practical nurse via company representative refers to a 16 year old non-pregnant female patient. The patient's medical history including fainting after receiving unspecified vaccination shots. There was no concomitant medications reported. On 02-JUL-2015, the patient was vaccinated with third dose of the GARDASIL 9 0.5 ml, intramuscularly, (site, a lot# and expiry date were not reported). On the same day, after receiving GARDASIL 9 she fainted. There was no treatment given for the adverse event. On 03-JUL-2015, the patient recovered from the adverse event. The patient sought medical attention in the doctor's office. The relatedness between GARDASIL 9 and the event was not reported. Additional information is not expected as the reporter did not wish the further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender who on 29-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender who on 30-JUN-2015 was vaccinated with a dose of ROTATEQ (lot # K016313, expiration date was not reported) (dose and route not reported) that was 87 hours temperature excursion. The lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.