chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Eye swelling, Injection site swelling
Clinical narrative: Per reports from patient's mom after returning home, patient had swelling at injection site, and swelling to left eye. She took him to emergency room and was given benadryl and steroid shots.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Vaccine was administered higher than recommended. Noted red, raised and irritated at site of injection. Hot/warm to touch. Pt describes pain with palpation and warmth that travels from injection site to the shoulder. Induration is approximately 2 inches in length and 1 inch in width. This patient is being reported in case her reaction gets worse through the month.  Instructed patient to go to her primary clinic if symptoms worsen.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Injection site warmth, Product administered at inappropriate site
Clinical narrative: Vaccine was administered higher than recommended. Noted red, raised and irritated at site of injection. Hot/warm to touch. Pt describes pain with palpation and warmth that travels from injection site to the shoulder. Induration is approximately 2 inches in length and 1 inch in width. This patient is being reported in case her reaction gets worse through the month.  Instructed patient to go to her primary clinic if symptoms worsen.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient complains of severe pain in arm at site of injection developing in the night after he had vaccine. Area is red, slightly hot to touch, approximately size of large orange. No swelling above or below red area.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Six weeks after injection painful soreness in right upper arm persists. Limits range of motion for right arm when reaching up or back and for carrying moderately heavy things or raising out of bed.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Pt came in today, 3/4/18, for a CMR. I started talking about vaccines and he said he didn't want any more vaccines because his shoulder was still hurting after we gave him 2 vaccines in October. Pt says it started hurting the day after and still hurts today. It is his left shoulder. He says moving his arm makes it worse but nothing seems to make it better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue, Tongue blistering
Clinical narrative: Swelling and blisters on tongue. Patient visited PCP and started MEDROL 4mg Dosepak on 2/28/17.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed a bruise at the injection site. I saw it after 1 week, and it was healing (turning yellow), and after 2 weeks, when it was still yellow but almost healed. After 1 week, patient starting developing rashes on different parts of his body (arms, legs, torso). They are itchy and red.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient developed a bruise at the injection site. I saw it after 1 week, and it was healing (turning yellow), and after 2 weeks, when it was still yellow but almost healed. After 1 week, patient starting developing rashes on different parts of his body (arms, legs, torso). They are itchy and red.
Age: 8.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Pt's mother noticed a small red, swollen wheal around injection site. Pt states that it hurts but she had no fever. Mother gave her TYLENOL and BENADRYL. I advised mother to take pt to an ER if it gets worse and spreads.
Age: 8.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt's mother noticed a small red, swollen wheal around injection site. Pt states that it hurts but she had no fever. Mother gave her TYLENOL and BENADRYL. I advised mother to take pt to an ER if it gets worse and spreads.
Age: 8.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Large 2 inch diameter welt and redness at site of injection.
Age: 8.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Large 2 inch diameter welt and redness at site of injection.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Crying, Insomnia, Irritability, Lethargy, Pain
Clinical narrative: In the 12 hours following the vaccine, he was drowsy and somewhat lethargic - he developed a low-grade fever approximately 12 hours later and became extremely fussy. He has been uncontrollably crying off and on and acting in pain since 12 hours after the vaccination and has been unable to sleep more than 20 minutes at time over the last 48 hours.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Somnolence
Clinical narrative: In the 12 hours following the vaccine, he was drowsy and somewhat lethargic - he developed a low-grade fever approximately 12 hours later and became extremely fussy. He has been uncontrollably crying off and on and acting in pain since 12 hours after the vaccination and has been unable to sleep more than 20 minutes at time over the last 48 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Impaired work ability, Injection site rash, Malaise, Myalgia
Clinical narrative: Severe feelings of malaise, weakness, and muscle ache. Red rash about the size of an orange developed around injection site, extended in days following all the way to elbow. After a week reported that the rash was still present, very faint now and about the size of a half-dollar. Side effects developed the night of the injection. Wife missed day and 1/2 of work her symptoms were so bad. Called her primary care doctor the following day after the injection and she took ibuprofen which helped with the muscle pain.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Severe feelings of malaise, weakness, and muscle ache. Red rash about the size of an orange developed around injection site, extended in days following all the way to elbow. After a week reported that the rash was still present, very faint now and about the size of a half-dollar. Side effects developed the night of the injection. Wife missed day and 1/2 of work her symptoms were so bad. Called her primary care doctor the following day after the injection and she took ibuprofen which helped with the muscle pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Pain
Clinical narrative: On 3/2 patient received vaccine without incident. However, on 3/4 patient called the pharmacy complaining of severe soreness near the site of the injection and the upper part of her arm had felt hot. The patient state that it had improved from the day earlier with use of ibuprofen and a cold pack. Patient stated it only really hurt when she moved it and that it did not require medical attention. The patient stated it would probably be better in "a couple of day".
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Aggression, Asterixis, Blood aluminium, Crying, Decreased eye contact
Clinical narrative: On 10/27/17, my daughter was suddenly screaming at a high pitch for hours at a time. She was not even upset necessarily when she was screaming. For example, she would be sitting down calmly playing and suddenly the screaming would start again out of nowhere. She was persistently crying for hours and could not be consoled. She was arching her back while lying down. She suddenly had great difficulty sleeping when she had never had trouble before with this. In fact, she always got up around the same time every day and went to bed around the same time every day with no problems and was sleeping through the night; she had been doing this for several months prior to her immunizations on 10/13/2017. Now she was very restless, tossing and turning, crying, and waking up many times a night. It is like I suddenly had a different child. She was now throwing tantrums several times daily for just about anything, even small things. She no longer made eye contact or smiled. She could no longer crawl or move around as before. She could no longer sit without support and started involuntarily falling backwards while sitting on the floor. She lost the ability to say words she had already been speaking for some time. She was previously a rather easy-going child and became very irritable and fussy and aggressive. She developed a rash that would not heal. She began rocking back and forth a lot, head banging and flapping her arms, and developed involuntary twitches/jerks of her body in her arms and shoulders, all of which appeared to be signs of neurological damage from the vaccines. Patient has been seeing a specialist and undergoing a detoxification from all the vaccines for about three months now. She also sees a chiropractor regularly. She continues to take regular daily supplements which help correct her mutation and assist her in digesting foods, processing medications, and clearing toxins and chemicals from her body. She is slowly coming back to us. It is quite an uphill battle. Having a MTHFR gene mutation is clearly a contraindication for receiving vaccines. Approximately fifty percent of the population has at least one of the mutations (many of whom are not even aware they have it) and continue to receive vaccines. This appears to be an issue that could potentially create a true public health crisis one day.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Detoxification, Dyskinesia, Emotional distress, Encephalitis, Full blood count normal
Clinical narrative: On 10/27/17, my daughter was suddenly screaming at a high pitch for hours at a time. She was not even upset necessarily when she was screaming. For example, she would be sitting down calmly playing and suddenly the screaming would start again out of nowhere. She was persistently crying for hours and could not be consoled. She was arching her back while lying down. She suddenly had great difficulty sleeping when she had never had trouble before with this. In fact, she always got up around the same time every day and went to bed around the same time every day with no problems and was sleeping through the night; she had been doing this for several months prior to her immunizations on 10/13/2017. Now she was very restless, tossing and turning, crying, and waking up many times a night. It is like I suddenly had a different child. She was now throwing tantrums several times daily for just about anything, even small things. She no longer made eye contact or smiled. She could no longer crawl or move around as before. She could no longer sit without support and started involuntarily falling backwards while sitting on the floor. She lost the ability to say words she had already been speaking for some time. She was previously a rather easy-going child and became very irritable and fussy and aggressive. She developed a rash that would not heal. She began rocking back and forth a lot, head banging and flapping her arms, and developed involuntary twitches/jerks of her body in her arms and shoulders, all of which appeared to be signs of neurological damage from the vaccines. Patient has been seeing a specialist and undergoing a detoxification from all the vaccines for about three months now. She also sees a chiropractor regularly. She continues to take regular daily supplements which help correct her mutation and assist her in digesting foods, processing medications, and clearing toxins and chemicals from her body. She is slowly coming back to us. It is quite an uphill battle. Having a MTHFR gene mutation is clearly a contraindication for receiving vaccines. Approximately fifty percent of the population has at least one of the mutations (many of whom are not even aware they have it) and continue to receive vaccines. This appears to be an issue that could potentially create a true public health crisis one day.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Gene mutation identification test positive, Genetic counselling, Head banging, Insomnia, Irritability
Clinical narrative: On 10/27/17, my daughter was suddenly screaming at a high pitch for hours at a time. She was not even upset necessarily when she was screaming. For example, she would be sitting down calmly playing and suddenly the screaming would start again out of nowhere. She was persistently crying for hours and could not be consoled. She was arching her back while lying down. She suddenly had great difficulty sleeping when she had never had trouble before with this. In fact, she always got up around the same time every day and went to bed around the same time every day with no problems and was sleeping through the night; she had been doing this for several months prior to her immunizations on 10/13/2017. Now she was very restless, tossing and turning, crying, and waking up many times a night. It is like I suddenly had a different child. She was now throwing tantrums several times daily for just about anything, even small things. She no longer made eye contact or smiled. She could no longer crawl or move around as before. She could no longer sit without support and started involuntarily falling backwards while sitting on the floor. She lost the ability to say words she had already been speaking for some time. She was previously a rather easy-going child and became very irritable and fussy and aggressive. She developed a rash that would not heal. She began rocking back and forth a lot, head banging and flapping her arms, and developed involuntary twitches/jerks of her body in her arms and shoulders, all of which appeared to be signs of neurological damage from the vaccines. Patient has been seeing a specialist and undergoing a detoxification from all the vaccines for about three months now. She also sees a chiropractor regularly. She continues to take regular daily supplements which help correct her mutation and assist her in digesting foods, processing medications, and clearing toxins and chemicals from her body. She is slowly coming back to us. It is quite an uphill battle. Having a MTHFR gene mutation is clearly a contraindication for receiving vaccines. Approximately fifty percent of the population has at least one of the mutations (many of whom are not even aware they have it) and continue to receive vaccines. This appears to be an issue that could potentially create a true public health crisis one day.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Muscle twitching, Opisthotonus, Rash, Regressive behaviour
Clinical narrative: On 10/27/17, my daughter was suddenly screaming at a high pitch for hours at a time. She was not even upset necessarily when she was screaming. For example, she would be sitting down calmly playing and suddenly the screaming would start again out of nowhere. She was persistently crying for hours and could not be consoled. She was arching her back while lying down. She suddenly had great difficulty sleeping when she had never had trouble before with this. In fact, she always got up around the same time every day and went to bed around the same time every day with no problems and was sleeping through the night; she had been doing this for several months prior to her immunizations on 10/13/2017. Now she was very restless, tossing and turning, crying, and waking up many times a night. It is like I suddenly had a different child. She was now throwing tantrums several times daily for just about anything, even small things. She no longer made eye contact or smiled. She could no longer crawl or move around as before. She could no longer sit without support and started involuntarily falling backwards while sitting on the floor. She lost the ability to say words she had already been speaking for some time. She was previously a rather easy-going child and became very irritable and fussy and aggressive. She developed a rash that would not heal. She began rocking back and forth a lot, head banging and flapping her arms, and developed involuntary twitches/jerks of her body in her arms and shoulders, all of which appeared to be signs of neurological damage from the vaccines. Patient has been seeing a specialist and undergoing a detoxification from all the vaccines for about three months now. She also sees a chiropractor regularly. She continues to take regular daily supplements which help correct her mutation and assist her in digesting foods, processing medications, and clearing toxins and chemicals from her body. She is slowly coming back to us. It is quite an uphill battle. Having a MTHFR gene mutation is clearly a contraindication for receiving vaccines. Approximately fifty percent of the population has at least one of the mutations (many of whom are not even aware they have it) and continue to receive vaccines. This appears to be an issue that could potentially create a true public health crisis one day.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Restlessness, Screaming, Speech disorder developmental
Clinical narrative: On 10/27/17, my daughter was suddenly screaming at a high pitch for hours at a time. She was not even upset necessarily when she was screaming. For example, she would be sitting down calmly playing and suddenly the screaming would start again out of nowhere. She was persistently crying for hours and could not be consoled. She was arching her back while lying down. She suddenly had great difficulty sleeping when she had never had trouble before with this. In fact, she always got up around the same time every day and went to bed around the same time every day with no problems and was sleeping through the night; she had been doing this for several months prior to her immunizations on 10/13/2017. Now she was very restless, tossing and turning, crying, and waking up many times a night. It is like I suddenly had a different child. She was now throwing tantrums several times daily for just about anything, even small things. She no longer made eye contact or smiled. She could no longer crawl or move around as before. She could no longer sit without support and started involuntarily falling backwards while sitting on the floor. She lost the ability to say words she had already been speaking for some time. She was previously a rather easy-going child and became very irritable and fussy and aggressive. She developed a rash that would not heal. She began rocking back and forth a lot, head banging and flapping her arms, and developed involuntary twitches/jerks of her body in her arms and shoulders, all of which appeared to be signs of neurological damage from the vaccines. Patient has been seeing a specialist and undergoing a detoxification from all the vaccines for about three months now. She also sees a chiropractor regularly. She continues to take regular daily supplements which help correct her mutation and assist her in digesting foods, processing medications, and clearing toxins and chemicals from her body. She is slowly coming back to us. It is quite an uphill battle. Having a MTHFR gene mutation is clearly a contraindication for receiving vaccines. Approximately fifty percent of the population has at least one of the mutations (many of whom are not even aware they have it) and continue to receive vaccines. This appears to be an issue that could potentially create a true public health crisis one day.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Discomfort, Immediate post-injection reaction, Injection site pain, Limb discomfort
Clinical narrative: Immediately following the injection, I felt discomfort shoot down to the top of my right hand. My hand hurt for several days. Site area was sore. I thought this would resolve in a day or two. The injection site remained sore. It is now intermittent, but I have some discomfort every day. My arm is sore and I feel a mild burning discomfort. I cannot comfortably lie on my side to sleep on my right arm. Sometimes I do not notice the pain, it comes and goes, but every day, it hurts a little to a more moderate degree. As I type this it has been uncomfortable for several hours. I am active, use my arms and hands a lot. Activity does not reduce the pain.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Immediately following the injection, I felt discomfort shoot down to the top of my right hand. My hand hurt for several days. Site area was sore. I thought this would resolve in a day or two. The injection site remained sore. It is now intermittent, but I have some discomfort every day. My arm is sore and I feel a mild burning discomfort. I cannot comfortably lie on my side to sleep on my right arm. Sometimes I do not notice the pain, it comes and goes, but every day, it hurts a little to a more moderate degree. As I type this it has been uncomfortable for several hours. I am active, use my arms and hands a lot. Activity does not reduce the pain.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 62-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). On 16th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 17th February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, joint pain, tingling and fatigue. In February 2018, the outcome of the injection site swelling, joint pain, tingling and fatigue were recovered/resolved. The reporter considered the injection site swelling, joint pain, tingling and fatigue to be almost certainly related to SHINGRIX. Additional details were reported as follows: On 16th February 2018, at 11:23 hours, the patient received SHINGRIX in the right arm. On 17th February 2018, after receiving SHINGRIX, the patient experienced significant swelling at the injection site (the area was swollen to the size of a baseball), extreme fatigue (couldn't get out of bed for a few days), joint pain, and tingling on the right side of the body. The healthcare professional stated that the symptoms were very severe and took 2 to 3 days to resolve. At this point, symptoms were completely resolved. The patient did go to the doctor and the doctor told the patient to go back to the pharmacy to report it.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Injection site swelling, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 62-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). On 16th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 17th February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, joint pain, tingling and fatigue. In February 2018, the outcome of the injection site swelling, joint pain, tingling and fatigue were recovered/resolved. The reporter considered the injection site swelling, joint pain, tingling and fatigue to be almost certainly related to SHINGRIX. Additional details were reported as follows: On 16th February 2018, at 11:23 hours, the patient received SHINGRIX in the right arm. On 17th February 2018, after receiving SHINGRIX, the patient experienced significant swelling at the injection site (the area was swollen to the size of a baseball), extreme fatigue (couldn't get out of bed for a few days), joint pain, and tingling on the right side of the body. The healthcare professional stated that the symptoms were very severe and took 2 to 3 days to resolve. At this point, symptoms were completely resolved. The patient did go to the doctor and the doctor told the patient to go back to the pharmacy to report it.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Axillary pain, Burning sensation, Erythema, Groin pain, Papule
Clinical narrative: 28-year-old male presenting one week to the day after receiving an anthrax shot, his third in the series, and having symptoms arise starting 6 days ago with itching and irritation to the bilateral armpits. This progressed to the biceps and groin by Wednesday, and by Thursday when he was seen in clinic it was down to his elbows and across the anterior and posterior portions of his upper legs. In clinic on Thursday he was given 10 mg of IM dexamethasone, as well as diphenhydramine by mouth when necessary. He reports today having further spread throughout his arms onto the dorsum of bilateral hands as well as extending distally past the knees on the lower extremities. In the groin region rashes extended onto the shaft of the penis as well as the scrotum, and he states that it appears to be coming together in bilateral axilla surrounding the areas that have pubic hair. States that itching tends to build throughout the day, despite taking diphenhydramine, and that night it tends to be more of a burning sensation, but does keep him from immediately being able to go to sleep as he normally does. He states that otherwise he generally does not have very much itching in the early morning. He also notes that the papules and some cases or pustules and that he'll scratch them and open them relieving of clear fluid from beneath the skin. He denies any other previous allergies, no other previous allergic reactions, no other medications during the time of his immunization, and no other recent illnesses or constitutional symptoms associated with this reaction.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pruritus
Clinical narrative: 28-year-old male presenting one week to the day after receiving an anthrax shot, his third in the series, and having symptoms arise starting 6 days ago with itching and irritation to the bilateral armpits. This progressed to the biceps and groin by Wednesday, and by Thursday when he was seen in clinic it was down to his elbows and across the anterior and posterior portions of his upper legs. In clinic on Thursday he was given 10 mg of IM dexamethasone, as well as diphenhydramine by mouth when necessary. He reports today having further spread throughout his arms onto the dorsum of bilateral hands as well as extending distally past the knees on the lower extremities. In the groin region rashes extended onto the shaft of the penis as well as the scrotum, and he states that it appears to be coming together in bilateral axilla surrounding the areas that have pubic hair. States that itching tends to build throughout the day, despite taking diphenhydramine, and that night it tends to be more of a burning sensation, but does keep him from immediately being able to go to sleep as he normally does. He states that otherwise he generally does not have very much itching in the early morning. He also notes that the papules and some cases or pustules and that he'll scratch them and open them relieving of clear fluid from beneath the skin. He denies any other previous allergies, no other previous allergic reactions, no other medications during the time of his immunization, and no other recent illnesses or constitutional symptoms associated with this reaction.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Burning sensation, Insomnia, Papule, Pruritus, Rash generalised
Clinical narrative: 28-year-old male presenting one week to the day after receiving an anthrax shot, his third in the series, and having symptoms arise starting 6 days ago with itching and irritation to the bilateral armpits. This progressed to the biceps and groin by Wednesday, and by Thursday when he was seen in clinic it was down to his elbows and across the anterior and posterior portions of his upper legs. In clinic on Thursday he was given 10 mg of IM dexamethasone, as well as diphenhydramine by mouth when necessary. He reports today having further spread throughout his arms onto the dorsum of bilateral hands as well as extending distally past the knees on the lower extremities. In the groin region rashes extended onto the shaft of the penis as well as the scrotum, and he states that it appears to be coming together in bilateral axilla surrounding the areas that have pubic hair. States that itching tends to build throughout the day, despite taking diphenhydramine, and that night it tends to be more of a burning sensation, but does keep him from immediately being able to go to sleep as he normally does. He states that otherwise he generally does not have very much itching in the early morning. He also notes that the papules and some cases or pustules and that he'll scratch them and open them relieving of clear fluid from beneath the skin. He denies any other previous allergies, no other previous allergic reactions, no other medications during the time of his immunization, and no other recent illnesses or constitutional symptoms associated with this reaction.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash pustular, Skin irritation
Clinical narrative: 28-year-old male presenting one week to the day after receiving an anthrax shot, his third in the series, and having symptoms arise starting 6 days ago with itching and irritation to the bilateral armpits. This progressed to the biceps and groin by Wednesday, and by Thursday when he was seen in clinic it was down to his elbows and across the anterior and posterior portions of his upper legs. In clinic on Thursday he was given 10 mg of IM dexamethasone, as well as diphenhydramine by mouth when necessary. He reports today having further spread throughout his arms onto the dorsum of bilateral hands as well as extending distally past the knees on the lower extremities. In the groin region rashes extended onto the shaft of the penis as well as the scrotum, and he states that it appears to be coming together in bilateral axilla surrounding the areas that have pubic hair. States that itching tends to build throughout the day, despite taking diphenhydramine, and that night it tends to be more of a burning sensation, but does keep him from immediately being able to go to sleep as he normally does. He states that otherwise he generally does not have very much itching in the early morning. He also notes that the papules and some cases or pustules and that he'll scratch them and open them relieving of clear fluid from beneath the skin. He denies any other previous allergies, no other previous allergic reactions, no other medications during the time of his immunization, and no other recent illnesses or constitutional symptoms associated with this reaction.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Discomfort, Dyspnoea, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine given on 2/15/18 and no unexpected adverse effects until the evening of 2/17/18 when arm began to ache at about 11:00 pm. Discomfort disturbed sleep on 2/17 and 2/18 but I took MOTRIN although it really did not help. The on 2/19 the ache seemed to dissipate. The evening of 2/22, I remember my legs starting to itch but I just ignored it. I woke on 2/23 covered in hives: legs completely covered, arms and back just starting, my legs were obviously swelling. I was seen at our Health Care facility that afternoon by Physician Assistant who diagnosed condition as Serum Sickness. I was put on Prednisone: 20 mg x2 for 5 days. This was a Friday and the rash had cleared by Monday. But over weekend I started having trouble breathing and doctor prescribed an inhaler on Monday. I went in and saw doctor on Wednesday and received a breathing treatment, five more days of Prednisone and a chest X-ray.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Serum sickness, Sleep disorder, Urticaria
Clinical narrative: Vaccine given on 2/15/18 and no unexpected adverse effects until the evening of 2/17/18 when arm began to ache at about 11:00 pm. Discomfort disturbed sleep on 2/17 and 2/18 but I took MOTRIN although it really did not help. The on 2/19 the ache seemed to dissipate. The evening of 2/22, I remember my legs starting to itch but I just ignored it. I woke on 2/23 covered in hives: legs completely covered, arms and back just starting, my legs were obviously swelling. I was seen at our Health Care facility that afternoon by Physician Assistant who diagnosed condition as Serum Sickness. I was put on Prednisone: 20 mg x2 for 5 days. This was a Friday and the rash had cleared by Monday. But over weekend I started having trouble breathing and doctor prescribed an inhaler on Monday. I went in and saw doctor on Wednesday and received a breathing treatment, five more days of Prednisone and a chest X-ray.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Alopecia, Asthenia, Connective tissue disorder, Eye disorder, Fatigue
Clinical narrative: Cellulitis? Dermatitis? I noticed white material coming out of every single pore on my skin so I attempted to extract the material out of a certain spot but it almost seemed as if it was refilling. After that mild extraction attempt (which I do without any adverse reactions frequently) I started to have rapid onset (four hours) of facial swelling, blurry vision, and muscle spasms in my calves (I don't know if this was related to the vaccine but I've never had that problem before). Cephalexin and sulfamethoxazole-trimethoprim given. During the antibiotic course, the other side of my face swelled rapidly and I returned to the ER. What they believe is a connective tissue disorder (I'll have more information after a few more appointments) resulted from the reaction. I've had ongoing swelling, boils, hair loss, skin issues, intermittent weakness and constant fatigue. A host of eye problems as well (please contact me for further medical records).
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Furuncle, Laboratory test, Muscle spasms, Secretion discharge, Skin disorder
Clinical narrative: Cellulitis? Dermatitis? I noticed white material coming out of every single pore on my skin so I attempted to extract the material out of a certain spot but it almost seemed as if it was refilling. After that mild extraction attempt (which I do without any adverse reactions frequently) I started to have rapid onset (four hours) of facial swelling, blurry vision, and muscle spasms in my calves (I don't know if this was related to the vaccine but I've never had that problem before). Cephalexin and sulfamethoxazole-trimethoprim given. During the antibiotic course, the other side of my face swelled rapidly and I returned to the ER. What they believe is a connective tissue disorder (I'll have more information after a few more appointments) resulted from the reaction. I've had ongoing swelling, boils, hair loss, skin issues, intermittent weakness and constant fatigue. A host of eye problems as well (please contact me for further medical records).
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Vision blurred
Clinical narrative: Cellulitis? Dermatitis? I noticed white material coming out of every single pore on my skin so I attempted to extract the material out of a certain spot but it almost seemed as if it was refilling. After that mild extraction attempt (which I do without any adverse reactions frequently) I started to have rapid onset (four hours) of facial swelling, blurry vision, and muscle spasms in my calves (I don't know if this was related to the vaccine but I've never had that problem before). Cephalexin and sulfamethoxazole-trimethoprim given. During the antibiotic course, the other side of my face swelled rapidly and I returned to the ER. What they believe is a connective tissue disorder (I'll have more information after a few more appointments) resulted from the reaction. I've had ongoing swelling, boils, hair loss, skin issues, intermittent weakness and constant fatigue. A host of eye problems as well (please contact me for further medical records).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: This spontaneous report was received from currently 70-year-old, elderly, female patient who was reporting on herself. The patient did not have any pertinent medical history or any known drug reaction or allergies. On 05-JUN-2014, the patient was vaccinated with ZOSTAVAX, 1 dose in upper arm at pharmacy, lot # J014810 with an expiration date 21-FEB-2015, for shingles (route of administration was not reported). Concomitant therapies included MOTRIN, vitamins (MACULAR DEGENERATION VITAMIN'S) and AVASTIN injection. In approximately February 2018, reported as earlier this month, the patient was experiencing back pain. Subsequently, the patient was diagnosed with shingles and visited urgent care where she was prescribed valacyclovir and oxycodone (onset date in approximately February 2018, reported also as after receiving a ZOSTAVAX). There were no laboratory tests performed. Product quality complaint was not reported. The outcome of the events was not recovered. Causality assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. 16-FEB-2018, the patient was vaccinated with M-M-R II (albumin status was not reported) lot # N001532 with an expiration date 13-JAN-2019 for prophylaxis (dose, route of administration and anatomical location were not reported) that was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of M-M-R II experienced the temperature excursion form 47 degree Fahrenheit to 77 degrees Fahrenheit for 40 minutes. It was not reported if the was previous temperature excursion. A digital date logger was not involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 61-year-old female patient, reporting on herself. The patient's medical history included shingles on an unknown date in 2014 or 2015 (reported as "3 or 4 years ago"), again 2 months later and for the third time in September or October 2017. The patient's concurrent condition included allergies to an unspecified penicillin and DILAUDID. On an unknown date in November 2017, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported) to help prevent the recurrences of shingles. On 12-FEB-2018 the patient started to get rash on her leg and it was shingles again. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. Between 09-JAN-2018 and 16-FEB-2018, the patients were vaccinated with improperly stored doses of PROQUAD lot # N024563 with expiration date on 06-MAR-2019 (dose and route of administration were not reported) or improperly stored doses of VARIVAX lot # N017395 with expiration date on 07-JUN-2019 and lot # N008829 with expiration date on 16-MAR-2019. Properly stored doses of sterile diluent (MERCK) were used to reconstitute the doses of the vaccines. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 9 hours and 57 minutes. Data logger was involved in recording of the temperature excursions. There was a previous excursion of 15 to 46 degrees Fahrenheit for 33 hours reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions therapies were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) (lot # M029234, expiry date: 12-MAR-2019). On 14-FEB-2018, the patient was vaccinated with an expired dose of  M-M-R II lot # M006544, expiration date of 03-FEB-2018 for prophylaxis (dose, frequency and route of administration were not reported). No adverse effects were reported. Additionally, no product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, and refers to an immunodeficiency elderly patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, within a two year period, the patient was vaccinated with two doses of PNEUMOVAX 23, for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided). No adverse effects and no product quality complaint (PQC) was involved.
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother (medical assistant) via a company representative; referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in 2018 (also reported as "a few weeks ago"), the patient was vaccinated with her first dose of GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2018, the patient had one episode of vomiting after received her first dose of GARDASIL 9. At the reporting time, the outcome of vomiting was unknown. The causality assessment between the vomiting and vaccination with GARDASIL 9 was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 27-FEB-2018, the patient was vaccinated with an expired dose of VARIVAX (route, dose, frequency, and anatomical location were unknown) with lot # M009769 and expiration date 25-FEB-2018 for prophylaxis, reconstituted with sterile diluent (MERCK) with lot # M024786 and expiration date 19-FEB-2019. No adverse effects were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a physician and refers to a 12 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9 injection intramuscular for prevention of Human Papillomavirus (HPV) (anatomical location, lot number and expiration date were not reported). On an unknown date, the patient developed a lump the size of a quarter at the injection site (vaccination site mass), that lasted a little over a month. It was reported that the patient sought medical attention, however, no treatment was provided for the event and the patient had not received any additional doses of GARDASIL 9 due to this reaction but might complete the series at a later time. Additionally, it was reported that there might had been something wrong with the medical assistant's injection technique because there had been multiple other unspecified patients who had also developed a "lump" at the injection site after receiving unspecified injections administered by the same medical assistant. The reporter did not provided the causality assessment between the event vaccination site mass and therapy with GARDASIL 9.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-FEB-2018, the patient was vaccinated with an expired dose of VAQTA intramuscular route (dose, frequency, and anatomical location were unknown) with lot # M012261 and expiration date 01-FEB-2018 for prophylaxis. No adverse effect were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # N016993 and expiration date on 29-NOV-2018, for prophylaxis (dose, route of administration and anatomical location were not provided). The sterile diluent (MERCK) used for the reconstitution of the vaccine was properly stored. The administered dose of the vaccine experienced a temperature excursion of -14 to -10 degrees Celsius (°C) for 2 hours and 4 minutes, as recorded by a data logger. The vaccines had had a previous temperature excursion of -14 to -10 degrees Celsius (°C) for 2 hours and 5 minutes. There was no adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 01-MAR-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route on or about 28-MAR-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 04-NOV-2015, the patient was treated by a physician for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to currently 4-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 19-FEB-2018, the patient was vaccinated with improperly stored PROQUAD (Lot # N020618 and expiration date 22-JAN-2019), (Lot# N025923 and expiration date 18-MAR-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that PROQUAD (lot # N020618) could still be used.  Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.