chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old male patient who received SHINGRIX (batch number P3777, expiry date unknown). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included carvedilol, hydrochlorothiazide, LANOXIN, methotrexate, Multi Vitamin, Potassium, prednisone, tramadol, Vitamin B12, Vitamin B6 and ZESTRIL. On 9th March 2018, the patient received SHINGRIX .5 ml. On 9th March 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and pain in arm. On 11th March 2018, the patient experienced chest pressure. On 12th March 2018, the patient experienced diarrhea. On 13th March 2018, the patient experienced sickness. On 14th March 2018, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, rash, sickness, tiredness and pain in arm were not recovered/not resolved and the outcome of the chest pressure and diarrhea were recovered/resolved. The reporter considered the shingles to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the rash, sickness and diarrhea to be related to SHINGRIX. The reporter considered the chest pressure, tiredness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The patient received ELIQUIS, LASIX and EYECAP as concomitant. 5 days, after receiving SHINGRIX, the night before reporting date, the patient broke out in a rash in the front and the back of his chest which the reporter believed was shingles. The patient was tired and in bed all day and he did not feel well. On Monday, 3 days after receiving SHINGRIX, the patient had diarrhea. 2 days, after receiving SHINGRIX, the patient felt pressure in his chest a couple of days ago and he thought he was having a heart attack. The patient's arms were sore and achy and felt like he had a bug.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX. Co-suspect products included DTPa vaccine. On 14th March 2018 09:00, the patient received the 1st dose of SHINGRIX. On 14th March 2018, the patient received the 1st dose of dTpa vaccine. On 14th March 2018 08:00, 11 hrs after receiving SHINGRIX and less than a day after receiving dTpa vaccine, the patient experienced headache, sweating, muscle pain, fever, shivering and weakness. The patient was treated with BENADRYL, TYLNEOL and SINUTAB. On an unknown date, the outcome of the headache, sweating, muscle pain, fever, shivering and weakness were not recovered/not resolved. The reporter considered the headache, sweating, muscle pain, fever, shivering and weakness to be related to SHINGRIX. It was unknown if the reporter considered the headache, sweating, muscle pain, fever, shivering and weakness to be related to dTpa vaccine. Additional details were provided as follows: Sibling reported that her sister received SHINGRIX vaccine around 9:00 am and at 8:00 pm in the evening of vaccination day she experienced all the events. She explained that her head was killing her. The patient also had a TDAP vaccination on the same day but the vaccine was something that she had received many times since she gets the vaccine every 10 years. She took a SINUTAB around 10:00 pm in the evening of vaccination day and BENADRYL around 4:00 am and two TYLENOL between 8:00 to 9:00 am in the next morning. There had been no improvement in the side effects. On the day of reporting, she explained that her side effects were worse.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX. Co-suspect products included DTPa vaccine. On 14th March 2018 09:00, the patient received the 1st dose of SHINGRIX. On 14th March 2018, the patient received the 1st dose of dTpa vaccine. On 14th March 2018 08:00, 11 hrs after receiving SHINGRIX and less than a day after receiving dTpa vaccine, the patient experienced headache, sweating, muscle pain, fever, shivering and weakness. The patient was treated with BENADRYL, TYLNEOL and SINUTAB. On an unknown date, the outcome of the headache, sweating, muscle pain, fever, shivering and weakness were not recovered/not resolved. The reporter considered the headache, sweating, muscle pain, fever, shivering and weakness to be related to SHINGRIX. It was unknown if the reporter considered the headache, sweating, muscle pain, fever, shivering and weakness to be related to dTpa vaccine. Additional details were provided as follows: Sibling reported that her sister received SHINGRIX vaccine around 9:00 am and at 8:00 pm in the evening of vaccination day she experienced all the events. She explained that her head was killing her. The patient also had a TDAP vaccination on the same day but the vaccine was something that she had received many times since she gets the vaccine every 10 years. She took a SINUTAB around 10:00 pm in the evening of vaccination day and BENADRYL around 4:00 am and two TYLENOL between 8:00 to 9:00 am in the next morning. There had been no improvement in the side effects. On the day of reporting, she explained that her side effects were worse.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Started with fever that day, not measured by family. Fever lasted 1.5 days. Patient vomited everyday since the shot and last vomited 3/28/18. Also has watery diarrhea since 3/24/18 which is now thickened up as of 3/29/18.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash, Urticaria
Clinical narrative: Pt developed delayed redness and swelling at injection site hives and skin rash irregular shapes w/bumps approx. 2 in. Developed fever. Given oral Benadryl and TYLENOL.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Acute cellulitis. Appeared evening of administration. Patient hospitalized for 3 days.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Developed rash on forearms of both arms, itchy but not painful, has since subsided on 3/29/18.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: MMRV vaccine expired 2/13/18. Provider and parent contacted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Asthenia, Blister, Depressed mood, Fall
Clinical narrative: Immune system broken. I felt sick and weak. Clear blisters appeared in (L) forearm. Tiny red rashes appear with severe itch. They leave hard, itchy lines or spots on skin. Leave scars on scalp (head). (R) shoulder tendonitis osteoporosis. Seen by Orthopedics (cortisone inj, PT) Neurologist (MRI. New Dx Osteoporosis), and LFT's (Abdominal US). Seen by Hematologist. Decreased vision, hearing decreased, teeth. I did not know why I became so weak and lose energy. I had itches with mild cold often, but I didn't know what caused. I was seen by many specialists and had many tests done. But I didn't tell I was reacting to shingles vaccine, I didn't tell this suspicion until recently. Because, my hair stylist told me she can't do my hair care some parts on my head, because the skin is broken some spots. I itch and scratch my head almost every day. I start thinking I have skin disease. Now, I told my PCP Dr. in February, 2018 I think I have shingles. I should report it now. Dr., who was my PCP over twenty years retired a year ago did not know why I was so weak and had complaints of itchy scalp with hair loss often. He put Atorvastatin 20mg 1 tab daily and it helps me to walk again without a cane. It took many years I regained some immune back. I fell often. All my vision, hearing, breathing, soften teeth, etc need special treatments now. They are dangerously bad. I am very unhappy and want to know when I will recover my good health ever again. P.S. I enclosed a copy of shingles vaccine record of the doctor's office. There are days I feel I will stop breathing any minute. Please advise me. Thanks.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis, Immune system disorder, Laboratory test, Liver function test, Malaise
Clinical narrative: Immune system broken. I felt sick and weak. Clear blisters appeared in (L) forearm. Tiny red rashes appear with severe itch. They leave hard, itchy lines or spots on skin. Leave scars on scalp (head). (R) shoulder tendonitis osteoporosis. Seen by Orthopedics (cortisone inj, PT) Neurologist (MRI. New Dx Osteoporosis), and LFT's (Abdominal US). Seen by Hematologist. Decreased vision, hearing decreased, teeth. I did not know why I became so weak and lose energy. I had itches with mild cold often, but I didn't know what caused. I was seen by many specialists and had many tests done. But I didn't tell I was reacting to shingles vaccine, I didn't tell this suspicion until recently. Because, my hair stylist told me she can't do my hair care some parts on my head, because the skin is broken some spots. I itch and scratch my head almost every day. I start thinking I have skin disease. Now, I told my PCP Dr. in February, 2018 I think I have shingles. I should report it now. Dr., who was my PCP over twenty years retired a year ago did not know why I was so weak and had complaints of itchy scalp with hair loss often. He put Atorvastatin 20mg 1 tab daily and it helps me to walk again without a cane. It took many years I regained some immune back. I fell often. All my vision, hearing, breathing, soften teeth, etc need special treatments now. They are dangerously bad. I am very unhappy and want to know when I will recover my good health ever again. P.S. I enclosed a copy of shingles vaccine record of the doctor's office. There are days I feel I will stop breathing any minute. Please advise me. Thanks.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Nuclear magnetic resonance imaging, Ophthalmological examination, Osteoporosis, Pruritus
Clinical narrative: Immune system broken. I felt sick and weak. Clear blisters appeared in (L) forearm. Tiny red rashes appear with severe itch. They leave hard, itchy lines or spots on skin. Leave scars on scalp (head). (R) shoulder tendonitis osteoporosis. Seen by Orthopedics (cortisone inj, PT) Neurologist (MRI. New Dx Osteoporosis), and LFT's (Abdominal US). Seen by Hematologist. Decreased vision, hearing decreased, teeth. I did not know why I became so weak and lose energy. I had itches with mild cold often, but I didn't know what caused. I was seen by many specialists and had many tests done. But I didn't tell I was reacting to shingles vaccine, I didn't tell this suspicion until recently. Because, my hair stylist told me she can't do my hair care some parts on my head, because the skin is broken some spots. I itch and scratch my head almost every day. I start thinking I have skin disease. Now, I told my PCP Dr. in February, 2018 I think I have shingles. I should report it now. Dr., who was my PCP over twenty years retired a year ago did not know why I was so weak and had complaints of itchy scalp with hair loss often. He put Atorvastatin 20mg 1 tab daily and it helps me to walk again without a cane. It took many years I regained some immune back. I fell often. All my vision, hearing, breathing, soften teeth, etc need special treatments now. They are dangerously bad. I am very unhappy and want to know when I will recover my good health ever again. P.S. I enclosed a copy of shingles vaccine record of the doctor's office. There are days I feel I will stop breathing any minute. Please advise me. Thanks.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Respiration abnormal, Scar, Skin disorder, Skin induration
Clinical narrative: Immune system broken. I felt sick and weak. Clear blisters appeared in (L) forearm. Tiny red rashes appear with severe itch. They leave hard, itchy lines or spots on skin. Leave scars on scalp (head). (R) shoulder tendonitis osteoporosis. Seen by Orthopedics (cortisone inj, PT) Neurologist (MRI. New Dx Osteoporosis), and LFT's (Abdominal US). Seen by Hematologist. Decreased vision, hearing decreased, teeth. I did not know why I became so weak and lose energy. I had itches with mild cold often, but I didn't know what caused. I was seen by many specialists and had many tests done. But I didn't tell I was reacting to shingles vaccine, I didn't tell this suspicion until recently. Because, my hair stylist told me she can't do my hair care some parts on my head, because the skin is broken some spots. I itch and scratch my head almost every day. I start thinking I have skin disease. Now, I told my PCP Dr. in February, 2018 I think I have shingles. I should report it now. Dr., who was my PCP over twenty years retired a year ago did not know why I was so weak and had complaints of itchy scalp with hair loss often. He put Atorvastatin 20mg 1 tab daily and it helps me to walk again without a cane. It took many years I regained some immune back. I fell often. All my vision, hearing, breathing, soften teeth, etc need special treatments now. They are dangerously bad. I am very unhappy and want to know when I will recover my good health ever again. P.S. I enclosed a copy of shingles vaccine record of the doctor's office. There are days I feel I will stop breathing any minute. Please advise me. Thanks.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Tendonitis, Tooth disorder, Ultrasound abdomen, Vaccination complication, Visual impairment
Clinical narrative: Immune system broken. I felt sick and weak. Clear blisters appeared in (L) forearm. Tiny red rashes appear with severe itch. They leave hard, itchy lines or spots on skin. Leave scars on scalp (head). (R) shoulder tendonitis osteoporosis. Seen by Orthopedics (cortisone inj, PT) Neurologist (MRI. New Dx Osteoporosis), and LFT's (Abdominal US). Seen by Hematologist. Decreased vision, hearing decreased, teeth. I did not know why I became so weak and lose energy. I had itches with mild cold often, but I didn't know what caused. I was seen by many specialists and had many tests done. But I didn't tell I was reacting to shingles vaccine, I didn't tell this suspicion until recently. Because, my hair stylist told me she can't do my hair care some parts on my head, because the skin is broken some spots. I itch and scratch my head almost every day. I start thinking I have skin disease. Now, I told my PCP Dr. in February, 2018 I think I have shingles. I should report it now. Dr., who was my PCP over twenty years retired a year ago did not know why I was so weak and had complaints of itchy scalp with hair loss often. He put Atorvastatin 20mg 1 tab daily and it helps me to walk again without a cane. It took many years I regained some immune back. I fell often. All my vision, hearing, breathing, soften teeth, etc need special treatments now. They are dangerously bad. I am very unhappy and want to know when I will recover my good health ever again. P.S. I enclosed a copy of shingles vaccine record of the doctor's office. There are days I feel I will stop breathing any minute. Please advise me. Thanks.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Immune system broken. I felt sick and weak. Clear blisters appeared in (L) forearm. Tiny red rashes appear with severe itch. They leave hard, itchy lines or spots on skin. Leave scars on scalp (head). (R) shoulder tendonitis osteoporosis. Seen by Orthopedics (cortisone inj, PT) Neurologist (MRI. New Dx Osteoporosis), and LFT's (Abdominal US). Seen by Hematologist. Decreased vision, hearing decreased, teeth. I did not know why I became so weak and lose energy. I had itches with mild cold often, but I didn't know what caused. I was seen by many specialists and had many tests done. But I didn't tell I was reacting to shingles vaccine, I didn't tell this suspicion until recently. Because, my hair stylist told me she can't do my hair care some parts on my head, because the skin is broken some spots. I itch and scratch my head almost every day. I start thinking I have skin disease. Now, I told my PCP Dr. in February, 2018 I think I have shingles. I should report it now. Dr., who was my PCP over twenty years retired a year ago did not know why I was so weak and had complaints of itchy scalp with hair loss often. He put Atorvastatin 20mg 1 tab daily and it helps me to walk again without a cane. It took many years I regained some immune back. I fell often. All my vision, hearing, breathing, soften teeth, etc need special treatments now. They are dangerously bad. I am very unhappy and want to know when I will recover my good health ever again. P.S. I enclosed a copy of shingles vaccine record of the doctor's office. There are days I feel I will stop breathing any minute. Please advise me. Thanks.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: No adverse event
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for himself. He received PREVNAR 13 lot# L58154 in Jun2015 at single dose for immunization. He states that 2 days late, his arm from shoulder to elbow was beat red with a funny waffle design rash, wasn't smooth. He has pictures. When that disappeared after about a week or so, he noticed he was getting a lot of pain in his neck across his shoulders. He noticed most of his strength was gone in his left side. He couldn't use his left arm very well for lifting and holding. He states that his triceps and bicep had no strength or muscle tone. He found that he cannot rotate his neck to look over his left shoulder properly. He would have to shimmy himself around to look at what is on his left side. He went to a physician and the doctor diagnosed him with brachial neuritis also known as Parsonage-Turner syndrome. His doctor told him that it is not curable, just treatable and could be a long drawn out thing. He has to sleep on his right side because the pain in his arm, from his elbow to forearm, is too much, it is very painful. The patient recovered from redness and rash. The outcome of all other events was not recovered.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Back pain, Bronchitis, Hypotonia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for himself. He received PREVNAR 13 lot# L58154 in Jun2015 at single dose for immunization. He states that 2 days late, his arm from shoulder to elbow was beat red with a funny waffle design rash, wasn't smooth. He has pictures. When that disappeared after about a week or so, he noticed he was getting a lot of pain in his neck across his shoulders. He noticed most of his strength was gone in his left side. He couldn't use his left arm very well for lifting and holding. He states that his triceps and bicep had no strength or muscle tone. He found that he cannot rotate his neck to look over his left shoulder properly. He would have to shimmy himself around to look at what is on his left side. He went to a physician and the doctor diagnosed him with brachial neuritis also known as Parsonage-Turner syndrome. His doctor told him that it is not curable, just treatable and could be a long drawn out thing. He has to sleep on his right side because the pain in his arm, from his elbow to forearm, is too much, it is very painful. The patient recovered from redness and rash. The outcome of all other events was not recovered.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for himself. He received PREVNAR 13 lot# L58154 in Jun2015 at single dose for immunization. He states that 2 days late, his arm from shoulder to elbow was beat red with a funny waffle design rash, wasn't smooth. He has pictures. When that disappeared after about a week or so, he noticed he was getting a lot of pain in his neck across his shoulders. He noticed most of his strength was gone in his left side. He couldn't use his left arm very well for lifting and holding. He states that his triceps and bicep had no strength or muscle tone. He found that he cannot rotate his neck to look over his left shoulder properly. He would have to shimmy himself around to look at what is on his left side. He went to a physician and the doctor diagnosed him with brachial neuritis also known as Parsonage-Turner syndrome. His doctor told him that it is not curable, just treatable and could be a long drawn out thing. He has to sleep on his right side because the pain in his arm, from his elbow to forearm, is too much, it is very painful. The patient recovered from redness and rash. The outcome of all other events was not recovered.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Radiculitis brachial, Rash
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for himself. He received PREVNAR 13 lot# L58154 in Jun2015 at single dose for immunization. He states that 2 days late, his arm from shoulder to elbow was beat red with a funny waffle design rash, wasn't smooth. He has pictures. When that disappeared after about a week or so, he noticed he was getting a lot of pain in his neck across his shoulders. He noticed most of his strength was gone in his left side. He couldn't use his left arm very well for lifting and holding. He states that his triceps and bicep had no strength or muscle tone. He found that he cannot rotate his neck to look over his left shoulder properly. He would have to shimmy himself around to look at what is on his left side. He went to a physician and the doctor diagnosed him with brachial neuritis also known as Parsonage-Turner syndrome. His doctor told him that it is not curable, just treatable and could be a long drawn out thing. He has to sleep on his right side because the pain in his arm, from his elbow to forearm, is too much, it is very painful. The patient recovered from redness and rash. The outcome of all other events was not recovered.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Grip strength decreased, Pain in extremity
Clinical narrative: This is actually a FOLLOW UP to the initial event. I couldn't get the form to upload. The patient started with a pain in her arm. She came back on 3/23 (7 months later) and said she is now having leg pain and decreased grip strength in her hand.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Flushing, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 720270), concerns a 40-year-old, adult female patient. The patient's historical condition included vasovagal response (fainting, flushing) to every injection. The patient could remember since her first school vaccinations. The patient's current condition included asthma and allergic to codeine and mold/mildew. The patient's concomitant medications included Montelukast SOD, DULERA, EQUATE women's plus, PROAIR HFA and ibuprofen for an unknown indication. On 13-Oct-2017, the patient was administered with influenza vaccine, (dose: 1 (as reported), route of administration: injection, anatomical location: left arm, manufacturer, trade name, batch number and expiry date: not reported). On the same day, within 5 minutes of vaccination, the patient had flushing and was resolved within 15 minutes. About an hour after injection, the patient had muscle soreness and swelling at the injection site. At evening, the patient had dizziness, nausea, and general muscle aches and continued for 24 hours (all symptoms are mild). After 24 hrs, the patient had sore and mild swollen. The outcome of the events (injection site pain and swelling, nausea, dizziness, myalgia) was not recovered. The reporter assessed this case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Mycotic allergy, Nausea, Pain, Presyncope, Swelling
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 720270), concerns a 40-year-old, adult female patient. The patient's historical condition included vasovagal response (fainting, flushing) to every injection. The patient could remember since her first school vaccinations. The patient's current condition included asthma and allergic to codeine and mold/mildew. The patient's concomitant medications included Montelukast SOD, DULERA, EQUATE women's plus, PROAIR HFA and ibuprofen for an unknown indication. On 13-Oct-2017, the patient was administered with influenza vaccine, (dose: 1 (as reported), route of administration: injection, anatomical location: left arm, manufacturer, trade name, batch number and expiry date: not reported). On the same day, within 5 minutes of vaccination, the patient had flushing and was resolved within 15 minutes. About an hour after injection, the patient had muscle soreness and swelling at the injection site. At evening, the patient had dizziness, nausea, and general muscle aches and continued for 24 hours (all symptoms are mild). After 24 hrs, the patient had sore and mild swollen. The outcome of the events (injection site pain and swelling, nausea, dizziness, myalgia) was not recovered. The reporter assessed this case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 720270), concerns a 40-year-old, adult female patient. The patient's historical condition included vasovagal response (fainting, flushing) to every injection. The patient could remember since her first school vaccinations. The patient's current condition included asthma and allergic to codeine and mold/mildew. The patient's concomitant medications included Montelukast SOD, DULERA, EQUATE women's plus, PROAIR HFA and ibuprofen for an unknown indication. On 13-Oct-2017, the patient was administered with influenza vaccine, (dose: 1 (as reported), route of administration: injection, anatomical location: left arm, manufacturer, trade name, batch number and expiry date: not reported). On the same day, within 5 minutes of vaccination, the patient had flushing and was resolved within 15 minutes. About an hour after injection, the patient had muscle soreness and swelling at the injection site. At evening, the patient had dizziness, nausea, and general muscle aches and continued for 24 hours (all symptoms are mild). After 24 hrs, the patient had sore and mild swollen. The outcome of the events (injection site pain and swelling, nausea, dizziness, myalgia) was not recovered. The reporter assessed this case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Expired product administered, Injection site induration, Injection site pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 722835), concerns a 68-year-old, elderly female patient. The patient had no pertinent medical history, drug reactions or allergies. On 09-Oct-2017, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was administered with expired non-company product PNEUMOVAX 23 (batch number: L021367, expiry date: 05-Nov-2016, dose, route of administration, anatomical location: not reported). On the same day, the patient had soreness and induration at the injection site. At the time of the report, the patient was recovering from the events, soreness and induration at the injection site. The reporter assessed the case as non-serious.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Pain, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hives in a female patient who received SHINGRIX. On 19th March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced hives, pain in arm and extremities hot feeling of. On an unknown date, the outcome of the hives, pain in arm and extremities hot feeling of were unknown. It was unknown if the reporter considered the hives, pain in arm and extremities hot feeling of to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient got the SHINGRIX vaccine yesterday and her arms hurt and was hot and had itchy hives.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hives in a female patient who received SHINGRIX. On 19th March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced hives, pain in arm and extremities hot feeling of. On an unknown date, the outcome of the hives, pain in arm and extremities hot feeling of were unknown. It was unknown if the reporter considered the hives, pain in arm and extremities hot feeling of to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient got the SHINGRIX vaccine yesterday and her arms hurt and was hot and had itchy hives.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Hypoaesthesia, Pain in extremity, Spinal pain
Clinical narrative: Pain spine and extremities, numbness in both hands and feet.
Sex: U
Vaccine: HEPA, HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a billing manager refers to an unknown number of child patients of unknown ages or genders. No information was provided regarding the patients' concomitant medications, pertinent medical history, drug reactions or allergies. On multiple dates since 13-OCT-2017 until 17-FEB-2017, unspecified number of patients received improperly stored doses of ROTATEQ, orally (exact dose and dose number were not reported; lot # N010707 with the expiration date of 03-DEC-2018, and lot # N000193 with the expiration date of 20-OCT-2018) for prophylaxis. On multiple dates since 20-NOV-2017 until 20-FEB-2018, 18 unspecified patients received improperly stored doses of M-M-R II (therapy type recombinant Human albumin (rHA); exact dose, dose number, route of administration were not reported; lot # N009172 with the expiration date of 20-MAR-2018) for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute M-M-R II was stored properly. On multiple dates since 22-NOV-2017 until 21-FEB-2018, 19 unspecified patients received improperly stored doses of GARDASIL 9 (exact dose, dose number, route of administration were not reported; lot # N017686 with the expiration date of 02-FEB-2020) for prophylaxis. On multiple dates since 13-DEC-2017 until 23-FEB-2018, 20 unspecified patients were vaccinated with improperly stored doses of VAQTA (exact dose, dose number, route of administration were not reported; lot # N020689 with the expiration date of 22-OCT-2018) for prophylaxis. No adverse effects were reported. The administered doses of vaccines underwent multiple temperature excursions since 10-OCT-2017 (also reported as since 06-OCT-2017). Digital data logger was involved to capture the temperature excursions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513- 1803USA012773.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse reporting on herself, a 29 year old female patient. The patient had none pertinent medical history, concomitant medications, drug reactions, or allergies. Approximately on 26-FEB-2018 (reported as "2 weeks ago"), the patient was vaccinated with a 0.5 ml dose of VARIVAX injection (route of administration, lot #, expiration date were not reported) for prevention of chickenpox. Approximately on 10-MAR-2018 (reported as "2 days ago"), the patient discovered, that she was pregnant through a pregnancy test. Therefore, the vaccine exposure was in the first trimester of pregnancy. Pregnancy gestation was reported as "maybe a month". Last menstrual period was calculated as 12-FEB-2018 and Estimated Date of Delivery as 19-NOV-2018. The pregnancy outcome was pending and the fetal outcome was unknown. It was reported, that no adverse event (AE) was reported. No treatment was given for adverse event. The patient did not seek a medical attention.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Cellulitis
Clinical narrative: The literature report has been received from the authors in a published literature article as above concerning a 70 years old male patient. The patient with chronic lymphocytic leukemia (CLL) who was started on ibrutinib in March 2014. The patient presented to immunology clinic in September 2016 with reports of recurrent sinus infections. He reported 2 episodes of sinusitis in 2014 after starting ibrutinib and another 2 episodes in 2015 but was referred to immunology after 5 episodes of sinusitis in 2016 that required antibiotics. He denied any history of pneumonia or other recurrent infections; he was on acyclovir for recurrent herpes zoster and fluconazole for onychomycosis but no prophylactic antibiotics. Initial laboratory evaluation showed hypogammaglobulinemia (IgG 193 mg/dL (all subsets were low: IgG1 106 mg/dL, IgG2 86 mg/dL, IgG3 13 mg/dL, IgG4 0.5 mg/dL), IgA 7 mg/dL, IgM 4 mg/dL); tetanus titers were normal but streptococcal titers showed only 1 protective titer of 14. Unfortunately, no immunoglobulin levels or titers were checked before initiating ibrutinib so the patient's baseline before treatment was unknown. The pneumococcal polysaccharide vaccine (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were not reported) was given in October 2016 for prophylaxis; no response was seen with repeat titers drawn in December 2016. During this time, the patient developed another episode of sinusitis treated with levofloxacin and a foot cellulitis treated with cephalexin and trimethoprim plus sulfamethoxazole; ibrutinib was held for 1 week in the setting of these infections and then restarted. The decision was made to start the patient on 16 g of subcutaneous immunoglobulin per week in January 2017. At the most recent follow-up in September 2017, the patient continued to do well with no further infections or antibiotic courses since starting immunoglobulin (Ig) replacement therapy (IRT); his last trough IgG was 827 mg/dL and all subclasses were within normal limits. He remains on ibrutinib with good response of his CLL with adequate neutrophil and platelet counts. The outcome of no response to pneumococcal polysaccharide vaccine (manufacturer unknown) was unknown. The author related the event to pneumococcal polysaccharide vaccine (manufacturer unknown).
Sex: M
Vaccine: PPV
Symptoms: Hypogammaglobulinaemia, Sinusitis
Clinical narrative: The literature report has been received from the authors in a published literature article as above concerning a 70 years old male patient. The patient with chronic lymphocytic leukemia (CLL) who was started on ibrutinib in March 2014. The patient presented to immunology clinic in September 2016 with reports of recurrent sinus infections. He reported 2 episodes of sinusitis in 2014 after starting ibrutinib and another 2 episodes in 2015 but was referred to immunology after 5 episodes of sinusitis in 2016 that required antibiotics. He denied any history of pneumonia or other recurrent infections; he was on acyclovir for recurrent herpes zoster and fluconazole for onychomycosis but no prophylactic antibiotics. Initial laboratory evaluation showed hypogammaglobulinemia (IgG 193 mg/dL (all subsets were low: IgG1 106 mg/dL, IgG2 86 mg/dL, IgG3 13 mg/dL, IgG4 0.5 mg/dL), IgA 7 mg/dL, IgM 4 mg/dL); tetanus titers were normal but streptococcal titers showed only 1 protective titer of 14. Unfortunately, no immunoglobulin levels or titers were checked before initiating ibrutinib so the patient's baseline before treatment was unknown. The pneumococcal polysaccharide vaccine (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were not reported) was given in October 2016 for prophylaxis; no response was seen with repeat titers drawn in December 2016. During this time, the patient developed another episode of sinusitis treated with levofloxacin and a foot cellulitis treated with cephalexin and trimethoprim plus sulfamethoxazole; ibrutinib was held for 1 week in the setting of these infections and then restarted. The decision was made to start the patient on 16 g of subcutaneous immunoglobulin per week in January 2017. At the most recent follow-up in September 2017, the patient continued to do well with no further infections or antibiotic courses since starting immunoglobulin (Ig) replacement therapy (IRT); his last trough IgG was 827 mg/dL and all subclasses were within normal limits. He remains on ibrutinib with good response of his CLL with adequate neutrophil and platelet counts. The outcome of no response to pneumococcal polysaccharide vaccine (manufacturer unknown) was unknown. The author related the event to pneumococcal polysaccharide vaccine (manufacturer unknown).
Sex: U
Vaccine: HEPA, HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a billing manager refers to a child patient of unknown age or gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (exact dose, dose number, route of administration was not reported; lot # N020689 with the expiration date of 22-OCT-2018 (also reported as 22-OCT-2017)) for prophylaxis. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (exact dose, dose number, route of administration was not reported; lot # N017686 with the expiration date of 02-FEB-2020) for prophylaxis. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II (exact dose, dose number, route of administration was not reported; lot # N009172 with the expiration date of 20-MAR-2019) for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the vaccine was properly stored. On unknown dates, the patient was vaccinated with an unknown number of unspecified vaccines, reported as "multiple vaccines" and "everything else in the fridge". No adverse effects were reported. The administered doses of vaccines underwent multiple temperature excursions. Digital Data Logger was involved to capture the temperature excursions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA000902.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Contusion, Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Child developed Immune Thrombocytopenic Purpura with Bruising and platelets decreased to 14 8 weeks following MMR Vaccine-child has continued to have intermittent thrombocytopenia since ie chronic ITP. Requiring intermittent treatment with IVIG Followed by Hematology.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity, Periarthritis, Vaccination complication
Clinical narrative: Pain in upper arm. Lost range in motion. MD states patient has frozen shoulder syndrom due to vaccination.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Glassy eyes, Headache, Lacrimation increased, Malaise
Clinical narrative: Within three hours of the injection, patient had runny nose, runny  and glassy eyes, cough, and malaise. Within 12 hours, patient was in bed with myalgias, cough, headache, and somnolence.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Rhinorrhoea, Somnolence
Clinical narrative: Within three hours of the injection, patient had runny nose, runny  and glassy eyes, cough, and malaise. Within 12 hours, patient was in bed with myalgias, cough, headache, and somnolence.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Shivering/chills, muscle aches, nausea, fatigue - lasted about 24 hours, pain at injection site - lasted 36+ hours.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Periarthritis, Shoulder operation
Clinical narrative: PATIENT STATED SHE RECEIVED THE PPSV23 IN HER DELTOID AND BOOSTRIX IN HER TRICEP AREA.  SHE HAD EXCRUTIATING PAIN UPON ADMINISTRATION AND AFTER. SHE BELIEVES THE SHOT WAS GIVEN TOO HIGH IN THE DELTOID. SHE SEEKED MEDICAL CARE WITH HER PROVIDER 4 DAYS LATER AND HE STARTED HER ON PHYSICAL THERAPY FOR HER SHOULDER PAIN AND LOSS OF RANGE OF MOTION IN HER LEFT ARM. PATIENT HAD MRI IN JANUARY DUE TO CONTINUED PAIN AND LOSS OF RANGE OF MOTION. DIAGNOSED WITH TENDON TEARS AND FROZEN SHOULDER. PATIENT HAD SHOULDER SURGERY ON 15 MARCH TO RELEASE FROZEN SHOULDER.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Tendon rupture
Clinical narrative: PATIENT STATED SHE RECEIVED THE PPSV23 IN HER DELTOID AND BOOSTRIX IN HER TRICEP AREA.  SHE HAD EXCRUTIATING PAIN UPON ADMINISTRATION AND AFTER. SHE BELIEVES THE SHOT WAS GIVEN TOO HIGH IN THE DELTOID. SHE SEEKED MEDICAL CARE WITH HER PROVIDER 4 DAYS LATER AND HE STARTED HER ON PHYSICAL THERAPY FOR HER SHOULDER PAIN AND LOSS OF RANGE OF MOTION IN HER LEFT ARM. PATIENT HAD MRI IN JANUARY DUE TO CONTINUED PAIN AND LOSS OF RANGE OF MOTION. DIAGNOSED WITH TENDON TEARS AND FROZEN SHOULDER. PATIENT HAD SHOULDER SURGERY ON 15 MARCH TO RELEASE FROZEN SHOULDER.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria without angioedema, coughing, wheezing, or difficulty breathing; Began 1-2 hours after vaccine given. Unknown duration as patient was called to follow up on, and mother did not return call.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Blood thyroid stimulating hormone normal, Cold sweat, Feeling hot, Full blood count normal, Loss of consciousness
Clinical narrative: After injection she started experiencing a burning pain in arm which continued after leaving facility. States that pain was significant enough to have to use ice and NSAIDs. Next day still having significant pain and 1 syncopal episode- she felt clammy and warm and then sat down and lost consciousness. She is not sure how long she was not conscious.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test normal, Pain, Serum ferritin normal, Syncope, Thyroxine normal
Clinical narrative: After injection she started experiencing a burning pain in arm which continued after leaving facility. States that pain was significant enough to have to use ice and NSAIDs. Next day still having significant pain and 1 syncopal episode- she felt clammy and warm and then sat down and lost consciousness. She is not sure how long she was not conscious.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Vitamin B12 normal, Vitamin D
Clinical narrative: After injection she started experiencing a burning pain in arm which continued after leaving facility. States that pain was significant enough to have to use ice and NSAIDs. Next day still having significant pain and 1 syncopal episode- she felt clammy and warm and then sat down and lost consciousness. She is not sure how long she was not conscious.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pain, Insomnia
Clinical narrative: Right arm, severe pain, red raised knot at the injection site, approx. size of knot is baseball. Pain is ongoing hurts to move arm, feels like sharp stabbing pain all the way to the bone of the arm/muscle area. Hard to lift or move arm. This has been going on constantly since the shot was given. Unable to sleep at night. Pain has not subsided and it is now 3/30/18.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pain
Clinical narrative: Right arm, severe pain, red raised knot at the injection site, approx. size of knot is baseball. Pain is ongoing hurts to move arm, feels like sharp stabbing pain all the way to the bone of the arm/muscle area. Hard to lift or move arm. This has been going on constantly since the shot was given. Unable to sleep at night. Pain has not subsided and it is now 3/30/18.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information was received on 28-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 16-JUN-2014, the patient received the ZOSTAVAX (lot number and expiration date unknown) unknown route for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 16-JAN-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious progressive permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a result of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses and other losses and damages. Shingles outbreak and chronic pain were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Therapy non-responder
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable Other-HCP on behalf of physician reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age race/ethnicity and gender received four doses of PREVNAR 13, all on an unknown date, at single dose, for immunization. Lot number of the fourth dose was 918245; while lot numbers of the other doses were not reported. Relevant medical history and concomitant medications were unknown. It was reported that the four doses did not immunize the patient. Possible 5th dose will be required. Clinical outcome was unknown at time of this report. The information on the lot numbers has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018129036 Same reporter/drug/event, different patients; US-PFIZER INC-2018129213 Same reporter/drug/event, different patients.