chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Colitis, Computerised tomogram abdomen abnormal, Computerised tomogram head, Dizziness, Dysarthria
Clinical narrative: I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
Age: 56.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Extra dose administered, Fall, Full blood count, Hypersomnia, Hypertension
Clinical narrative: I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
Age: 56.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypotonia, Hypoxia, Inappropriate schedule of drug administration, Injection site pain, Malaise
Clinical narrative: I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
Age: 56.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Memory impairment, Muscular weakness, Narcolepsy, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
Age: 56.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Oxygen saturation decreased, Product use issue, Pyrexia, Scan with contrast, Viral titre
Clinical narrative: I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
Age: 56.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Vision blurred, Weight decreased
Clinical narrative: I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
Age: 56.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Conversion disorder, Crying, Feeling abnormal, Malaise
Clinical narrative: I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
Sex: U
Vaccine: PNC13
Symptoms: Arthralgia, Gait disturbance, Middle insomnia, Myalgia, Pain in extremity
Clinical narrative: Was administered the PREVNAR 13 vaccine at pharmacy. During the night awakened by severe pain in body wide muscle and joints, and had extreme difficulty in walking. Eased in the following days, but as of 08/20/2018 continues intermittent pain in cal., gluteus, and shoulder muscles and hip, hand and knee joints.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Post vaccines, patient experienced a slight rash on face. No acute distress. After monitoring patient for 10 minutes, rash disappeared with no treatment and HR, RR remained stable. No rash or redness at injection sites.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Erythema, edema, pain and warmth of upper extremity from shoulder to elbow. Onset within 5-8 hours of vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Glossodynia, Headache, Malaise
Clinical narrative: Patient complained of sore under tongue that presented 2 days after receiving vaccine. Patient was following up with PCP for further evaluation. She also complained of other "normal" adverse events of headache, chills, and generally just not feeling well.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site vesicles, Rash vesicular
Clinical narrative: Around the site of injection, patient had developed chickenpox like skin rash with blisters and reddening of the skin. RPh recommended patient to contact her primary MD ASAP.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Had a rash at site of injection - MD confirmed with patient that this was adverse effect - cortisone PRN.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Eye movement disorder, Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena, Tremor
Clinical narrative: Immediately after receiving the 2 vaccines patients eyes rolled back, fell over on exam table hands drew up and was shaking like in a seizure. We laid him down and placed cold packs on head and he regained consciousness and observed 20 min. and felt better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient claims arm still sore.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Myalgia, Swelling
Clinical narrative: Chills, swelling, muscle and joint pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling. Cellulitis right thigh. Pain, tender and warm. Started on cephalexin.
Age: 12.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Pt developed nausea/vomiting w/in 24 hrs of being given vaccination. No other signs or symptoms.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Dehydration, Diarrhoea
Clinical narrative: Patient had severe pain in her arm, nausea, vomiting and diarrhea. Patient went to Hospital. Patient was not admitted.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid oedema, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Patient had severe pain in her arm, nausea, vomiting and diarrhea. Patient went to Hospital. Patient was not admitted.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient had severe pain in her arm, nausea, vomiting and diarrhea. Patient went to Hospital. Patient was not admitted.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient had severe pain in her arm, nausea, vomiting and diarrhea. Patient went to Hospital. Patient was not admitted.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood glucose normal, Dyskinesia, Feeling abnormal, Seizure, Syncope
Clinical narrative: Vaccine was given in Pharmacy 8/13/18, pt was seen in office 8/22/18. Per dad, pt had been at lake all day the day prior to vaccination, possibly dehydrated. Pt received vaccine, developed ringing in the ears, couldn't hear, had to sit down. Within 3  minutes had eye rolling and whole body jerking that lasted 10-15 seconds. No incontinence of bowel or bladder noted. Pt was confused and pale for 1-2  minutes after, then was fine. EMT eval at scene, normal blood glucose and blood pressure.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tinnitus
Clinical narrative: Vaccine was given in Pharmacy 8/13/18, pt was seen in office 8/22/18. Per dad, pt had been at lake all day the day prior to vaccination, possibly dehydrated. Pt received vaccine, developed ringing in the ears, couldn't hear, had to sit down. Within 3  minutes had eye rolling and whole body jerking that lasted 10-15 seconds. No incontinence of bowel or bladder noted. Pt was confused and pale for 1-2  minutes after, then was fine. EMT eval at scene, normal blood glucose and blood pressure.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood glucose normal, Confusional state, Dyskinesia, Eye movement disorder, Hypoacusis
Clinical narrative: Vaccine was given in Pharmacy 8/13/18, pt was seen in office 8/22/18. Per dad, pt had been at lake all day the day prior to vaccination, possibly dehydrated. Pt received vaccine, developed ringing in the ears, couldn't hear, had to sit down. Within 3  minutes had eye rolling and whole body jerking that lasted 10-15 seconds. No incontinence of bowel or bladder noted. Pt was confused and pale for 1-2  minutes after, then was fine. EMT eval at scene, normal blood glucose and blood pressure.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pallor, Tinnitus
Clinical narrative: Vaccine was given in Pharmacy 8/13/18, pt was seen in office 8/22/18. Per dad, pt had been at lake all day the day prior to vaccination, possibly dehydrated. Pt received vaccine, developed ringing in the ears, couldn't hear, had to sit down. Within 3  minutes had eye rolling and whole body jerking that lasted 10-15 seconds. No incontinence of bowel or bladder noted. Pt was confused and pale for 1-2  minutes after, then was fine. EMT eval at scene, normal blood glucose and blood pressure.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable medical assistant. A 65-year-old female patient received on 13Aug2018 PREVNAR 13,(lot T85621, NDC number 0005-1971-02, Expiry Date: 31Mar2020) at 0.5 ml single intramuscular in the arm as preventative care. Concomitant medications were not reported. Medical history was none. Few hours after she got the vaccine (Aug2018), injection site was red, hot and swollen and then she had a rash and said that she has had fever off and on. On 17Aug2018 patient presented to urgent care with that arm all red and inflamed. It all started after she got the vaccine like and then it just continued to worsen and was still getting worsened (later reporter mentioned she did not know the outcome of the events). Medical assistant sent patient to urgent care (not at emergency room) where patient was treated with steroids and antibiotics. Treatment started on 17Aug2018.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable medical assistant. A 65-year-old female patient received on 13Aug2018 PREVNAR 13,(lot T85621, NDC number 0005-1971-02, Expiry Date: 31Mar2020) at 0.5 ml single intramuscular in the arm as preventative care. Concomitant medications were not reported. Medical history was none. Few hours after she got the vaccine (Aug2018), injection site was red, hot and swollen and then she had a rash and said that she has had fever off and on. On 17Aug2018 patient presented to urgent care with that arm all red and inflamed. It all started after she got the vaccine like and then it just continued to worsen and was still getting worsened (later reporter mentioned she did not know the outcome of the events). Medical assistant sent patient to urgent care (not at emergency room) where patient was treated with steroids and antibiotics. Treatment started on 17Aug2018.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable medical assistant. A 65-year-old female patient received on 13Aug2018 PREVNAR 13,(lot T85621, NDC number 0005-1971-02, Expiry Date: 31Mar2020) at 0.5 ml single intramuscular in the arm as preventative care. Concomitant medications were not reported. Medical history was none. Few hours after she got the vaccine (Aug2018), injection site was red, hot and swollen and then she had a rash and said that she has had fever off and on. On 17Aug2018 patient presented to urgent care with that arm all red and inflamed. It all started after she got the vaccine like and then it just continued to worsen and was still getting worsened (later reporter mentioned she did not know the outcome of the events). Medical assistant sent patient to urgent care (not at emergency room) where patient was treated with steroids and antibiotics. Treatment started on 17Aug2018.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Burning sensation, Chills, Feeling cold, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: Patient brought in by mother acutely for complaints of having low-grade fever, body aches and chills.  Also nauseated. He feels sleepy and has slightly stiff neck. Patient was seen yesterday for his 16-year-old wellness exam. He was given MENACTRA, FLUZONE and TRUMENBA. He has no sore throat. No cough symptoms. Negative for runny nose. He has no confusion. He has no diarrhea or urinary symptoms. Negative for rash. His main complaint is that of chills, feels like his body is burning up and body ache. It is flulike symptoms. He has had no foreign travel or unusual exposure. He was not sick yesterday. He is an otherwise healthy individual who is progressing and meeting all milestones. He is academically strong and has been healthy through time. No prior reaction to any immunizations in the past. He did do well with flu shots in the past as well as MENACTRA.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: Patient brought in by mother acutely for complaints of having low-grade fever, body aches and chills.  Also nauseated. He feels sleepy and has slightly stiff neck. Patient was seen yesterday for his 16-year-old wellness exam. He was given MENACTRA, FLUZONE and TRUMENBA. He has no sore throat. No cough symptoms. Negative for runny nose. He has no confusion. He has no diarrhea or urinary symptoms. Negative for rash. His main complaint is that of chills, feels like his body is burning up and body ache. It is flulike symptoms. He has had no foreign travel or unusual exposure. He was not sick yesterday. He is an otherwise healthy individual who is progressing and meeting all milestones. He is academically strong and has been healthy through time. No prior reaction to any immunizations in the past. He did do well with flu shots in the past as well as MENACTRA.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 66 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant medications and drug reactions was not provided. On 23-JUL-2018 the patient inadvertently received an expired dose of PNEUMOVAX 23)(1 dosage form (DF); lot # M043424; expiration date 06-JUN-2018; route and site of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a male patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, batch/lot # and expiration date were unknown) for prophylaxis. On an unknown date, the patient stated the injection site and the shoulder was painful. It was also reported that the patient experienced injection site reaction on unspecified date. Information about treatment given for the events and lab diagnostics/studies was unknown by reporter. The patient visited the physician and sought medical attention. The outcome of the events was reported as recovering (reported as the patient was getting better but it was not completely resolved). The causality between PNEUMOVAX 23 and the events was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Gait inability, Rash
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (no details of the first dose administration were provided). On an unknown date, after the patient's second dose of GARDASIL 9, the patient experienced rash and was unable to walk. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 27-JUL-2018, the patient was vaccinated with properly stored but expired PROQUAD for prophylaxis (lot number N002916 and expiration date 24-JUL-2018) (expired product administered) (dose, frequency, route of administration and anatomical location were not reported). No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow-up information was received from nurse on 08-AUG-2018. This report refers to 5-year-old female patient. Other suspect therapies included KINRIX.
Age: 0.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse referring to a 11 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On day before the patient turned 12 months of age which was outside the recommended age according to the prescribing information, the patient was administered Oka/Merck VARIVAX (strength, dose, route, frequency were not reported, lot # 1702Y and expiration date 04-DEC-2011) and (wistar ra 27-3) M-M-R II  (strength, dose, route, frequency were not reported, therapy type: rHA, lot # 1367Y and expiration date 25-SEP-2011) for prophylaxis. No adverse effects were reported.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 3 month old male patient with prophylaxis. On 06-AUG-2018 the patient was vaccinated with improperly stored LIQUID PEDVAXHIB lot # R001085 dose 1 in the right thigh for prophylaxis (product storage error). Other suspect therapies included PEDIARIX, PREVNAR and ROTATEQ. No adverse events reported. Patient did not have any reverse reactions to the vaccines.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a female consumer via company representative referring to her daughter as a 18 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date of August 2016, the patient was vaccinated with first dose of GARDASIL 9 (lot, expiry date, dose and route of administration were not reported) for prophylaxis. On an unknown date of 2017, the patient was vaccinated with second dose of GARDASIL 9 (lot, expiry date, dose and route of administration were not reported) for prophylaxis. The patient's mother reported that "her daughter had received the first two doses of GARDASIL 9 outside of the recommended dosage schedule". It was reported that, the patient was currently looking to get the third dose. No product quality complaint was filed.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown gender who was currently 1 year old. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA 25/0.5, lot # N020689, expiry date: 22-OCT-2018 intramuscularly for prophylaxis (dosing details, anatomical location was not reported) (product storage error). The vaccine underwent temperature excursion of 10.47 degree Celsius for the time frame of 4 hours. There was no previous temperature excursion reported. Data logger involved. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA008623:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown gender who was currently 1 year old. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA 25/0.5, lot # N020689, expiry date: 22-OCT-2018 intramuscularly for prophylaxis (dosing details, anatomical location was not reported) (product storage error). The vaccine underwent temperature excursion of 10.47 degree Celsius for the time frame of 4 hours. There was no previous temperature excursion reported. Data logger involved. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA008484:
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA218718, 2018SA223733, 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves five-year-old (five year six months) patient of an unknown age who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA218718, 2018SA223733, 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves four-year-old (four year 14 days) patient of an unknown age who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old female patient who was vaccinated with an 0.5 ml expired dose of MENACTRA (Batch number: U5513AA and expired date: 09-Mar-2018) (dose in series and route was not reported) in the right deltoid on 09-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used because patient was administered expired MENACTRA yesterday on 09-Aug-2018. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 16 month old male patient who was vaccinated with (0.5 ml x 2) third dose of ACTHIB (frequency once, batch number U6110AA, expiry date 21-JAN-2020) intramuscularly in left thigh on 13-AUG-2018. It was a case of actual medication error as product preparation error as mixed 2 ACTHIB (0.5 ml x 2) diluents together and administered as a vaccine. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: Initial pregnancy report received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA225861 (same reporter). This case involves 38-year-old female patient who was exposed to 0.5 ml dose of vaccine ADACEL (Batch number: U5979AA and expiry date: 13-Jun-2020) (dose in series and route was not reported) in the left deltoid on 09-Aug-2018, in context of received injection that was out of shipping stability and this patient was pregnant and was 26 weeks 5 days pregnant and vaccinated. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient exposed to vaccine at 26 Weeks 5 days of pregnancy. The date of last menstrual period was not reported. The estimated due date was Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage as the patient received injection that was out of shipping stability. It was also a case of vaccine exposure during pregnancy. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by the sender: None.