chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Aplasia cutis congenita, Foetal exposure during pregnancy
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 25-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero included lavender oil, prenatal vitamins, doxylamine, wine, docosahexaenoic acid, folic acid, zinc, magnesium, ubidecarenone, copper, selenium, zingiber officinale rhizome, green or black tea, unspecified antibiotics, OXYCOCET, ondansetron, progesterone, magnesium hydroxide, paracetamol, docusate sodium, calcium carbonate, hydrocortisone, oenothera biennis oil and miconazole nitrate. The 34-year-old mother had medical history of BRCA1 gene mutation, chronic fatigue syndrome (in 2007), was suspected to have Raynaud's and also had history of uterine cysts (in 2007) (refer to the mother case 2015052718). On 17-Oct-2014, the patient received AFLURIA vaccine (batch number not reported) at 1 shot 1x QD, in-utero via the mother. On 04-Nov-2014, the patient's mother underwent ultrasound scan which was normal. On 02-Dec-2014, the patient's mother underwent first trimester serum screen, the result of which was normal. On 12-Dec-2014, the patient's mother underwent an ultrasound scan and on 01-Jan-2015, she underwent alpha fetoprotein test, both of which were normal. On the 02-Feb-2015, the patient's mother underwent an ultrasound scan which was normal. On 21-Mar-2015, she underwent glucose tolerance test which was normal. On the 17-Apr-2015, the patient also received TDAP vaccine (batch number not reported) at 1 shot per day, in-utero via the mother. On the 28-Apr-2015 and 01-May-2015, the patient's mother underwent a non-stress/stress test. On the 01-May-2015, she also underwent an ultrasound which was normal. On the 19-May-2015, the patient's mother underwent a non-stress/stress test and on the 29-May-2015, the patient's mother underwent an ultrasound which was normal. The patient was born (gestational age of delivery 40.3), and was diagnosed with aplasia cutis congenita at delivery. The patient's birth weight was 3093 grams and Apgars at 1 min was 8 and Apgars at 5 mins was 9. The outcome was not reported. Reporter comments: The reporter assessed the event as serious (congenital anomaly).
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pruritus, Rash erythematous, Throat tightness
Clinical narrative: Itching upper back and chest and face/mouth. No shortness of breath but some tightness in throat. Faint red rash on upper chest and upper back.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Pallor
Clinical narrative: Diaphoretic, pale, shortness of breath, wheezing, rapid HR, hands numb tingling, faint pulse.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Pulse abnormal, Wheezing
Clinical narrative: Diaphoretic, pale, shortness of breath, wheezing, rapid HR, hands numb tingling, faint pulse.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscle twitching, Syncope
Clinical narrative: Adminsitered Tdap in right deltoid, then Menactra in left deltoid.  Patient fainted after second vaccination and had twitchy hand movements.  Had not eaten at all that day before receiving immunizations.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: REDNESS AND SWELLING AT VACCINATION SITE L DELTOID. AREA HOT TO TOUCH AND TENDER TO TOUCH. MOM STATES, SWELLING INCREASING.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Asthenia, Blood pressure decreased, Blood test, Computerised tomogram, Dizziness
Clinical narrative: Dizziness, Diaphoretic, Fainting, Decreased BP, Decreased HR. Pt remained in health dept for approx. 1hr 15 min. Pt was transferred to ER via ambulance at 12:35 (2nd time EMS came) EMS called at the initial time, evaluated by EMS, then EMS left. Recalled at 12:21pm for symptoms not improving and patient with severe headache at 12:09. Pt received bloodwork and CT scan at ER.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Headache, Heart rate decreased, Hyperhidrosis, Syncope
Clinical narrative: Dizziness, Diaphoretic, Fainting, Decreased BP, Decreased HR. Pt remained in health dept for approx. 1hr 15 min. Pt was transferred to ER via ambulance at 12:35 (2nd time EMS came) EMS called at the initial time, evaluated by EMS, then EMS left. Recalled at 12:21pm for symptoms not improving and patient with severe headache at 12:09. Pt received bloodwork and CT scan at ER.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Joint range of motion decreased, Lethargy, Malaise, Pain
Clinical narrative: PT reports swelling, erythema, hot to the touch, satellite welts, general malaise, lethargy, tenderness and reduced range of motion due to swelling and pain that had a gradual onset and sustained for three days. Self treatment included icing, rest and ibuprofen 400mg by mouth every 6 hours for three days and found relief.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Skin warm, Swelling, Tenderness, Urticaria, Vaccine positive rechallenge
Clinical narrative: PT reports swelling, erythema, hot to the touch, satellite welts, general malaise, lethargy, tenderness and reduced range of motion due to swelling and pain that had a gradual onset and sustained for three days. Self treatment included icing, rest and ibuprofen 400mg by mouth every 6 hours for three days and found relief.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy, Vaccination site cellulitis
Clinical narrative: This is a spontaneous report from a contactable nurse. A 55 year-old female patient received on 15Jul2015 a single dose of PREVNAR 13 (lot/batch number L62075, expiry date Dec2016, NDC number: 0005197102) intramuscular in the right deltoid. Relevant medical history included regular hypercholesterol, depression and thyroid problems. Concomitant medications included: NEXIUM at 40 mg, SYNTHROID at 50 ug, MIRAPEX (tablet) 0.25 mg, (one to two tablet), PROAIR, XANAX at 0.5 mg, BREO ELLIPTA. The patient experienced cellulitis in the right arm where she received vaccine at site of injection and lymph node swelling in the right axis (axillary and epitrochlear) on 19Jul2015. The patient took amoxicillin for the treatment of the events and she did not perform laboratory works. The patient recovered from the events on unknown date. The nurse was sure that the vaccine caused the cellulitis and lymph node swelling because it was after she got the vaccine. The nurse mentioned that as of now patient was not suffering from these events. Causality: The nurse mentioned all these adverse events were due to PREVNAR 13.
Age: 38.0
Sex: U
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Bone pain, Muscle spasms
Clinical narrative: Pain in the joints, bones, and back; muscular spasms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysaesthesia, Ear pain
Clinical narrative: (L) ear pain and dysethesia corresponding to check up distribution, no rash; onset shortly after Zoster immunization.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction noted. Extra dose of MMR received.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Severe stiffness and pain in neck on right side (the vaccine was administered in the right arm).
Age: 1.01
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Injection site urticaria, Pyrexia
Clinical narrative: Hive like rash appeared on left leg injection was given and spread to left arm as well and developed fever of 100.4.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Nerve pain at injection site and near right shoulder blade. No rash identified.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Patient broke out with what looked like bug bites down her left leg.  By the end of the day, they were on her arm also.  The next day, it was on both legs and both arms.  By the third day, she had the outbreak on her neck, face, feet, and a few on her back.  She continued to have new pox pop up for two weeks.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Hypoacusis, Posture abnormal, Tremor
Clinical narrative: Pt with brief moment where head dropped down and began shaking uncontrollably. Symptoms recognized and lasted for 5 seconds after administration of HPV. Once patient lifted her head she reported voices being muffled and feeling dizzy. FNP-C called in room and patient was taken to exam room 17 via wheelchair to rest. Pt was given cool cloth and reported feeling better after a few minutes. Pt's step mother was called after verifying that it was ok with patient and came to pick patient up. Pt instructed to go to Emergency Room if symptoms were to return and she verbalized understanding. Pt was able to walk out to vehicle with assistance.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Dysphemia
Clinical narrative: Sudden onset stuttering. Has never stuttered before, it progressively got worse over the next few days. On Friday am, I consulted his pedi and she said take him to the emergency room. They did no diagnostics and sent us home. It got very bad over the next week and then all of the sudden got a lot better. He is still having stuttering difficulties to this day but has gotten better since the first week.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Fatigue, Irritability, Pyrexia, Rash, Rash generalised
Clinical narrative: Patient's symptoms started out with overall irritability, low-grade fever and increased fatigue, noted by increase in naps. The symptoms persisted and intensified over night and into the next morning, with the fever rising to 103.5 degrees F by late morning. Dr. was called and advised administering Tylenol or Ibuprofen, however parents preferred a holistic approach. Consultation with a homeopathic relative was taken, and parents administered topical treatments of peppermint oil throughout the day, and later a cooler bath, which both aided in reducing the fever to 98.1. After the fever subsided, that night the patient experienced a breakout of an itching skin rash beginning on the back and spread over the body. Treatment for the rash included application of mostly Melaleuca (Tea Tree) oil and some Frankincense oil. Both were successful at controlling the itchiness associated with the rash. Symptoms cleared up after a few days.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Rash pruritic, Somnolence
Clinical narrative: Patient's symptoms started out with overall irritability, low-grade fever and increased fatigue, noted by increase in naps. The symptoms persisted and intensified over night and into the next morning, with the fever rising to 103.5 degrees F by late morning. Dr. was called and advised administering Tylenol or Ibuprofen, however parents preferred a holistic approach. Consultation with a homeopathic relative was taken, and parents administered topical treatments of peppermint oil throughout the day, and later a cooler bath, which both aided in reducing the fever to 98.1. After the fever subsided, that night the patient experienced a breakout of an itching skin rash beginning on the back and spread over the body. Treatment for the rash included application of mostly Melaleuca (Tea Tree) oil and some Frankincense oil. Both were successful at controlling the itchiness associated with the rash. Symptoms cleared up after a few days.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling of the arm from 15cm to 21 cm in circumference around the bicep, firmness of the skin approximate 10 centimeters in diameter around injection site. Signs and symptoms took less than 48 hours to occur child was taken to the health clinic where the vaccine was given for check up. The child was given antibiotics and a cold pack regiment to treat. The child still has the symptoms and is currently being monitored by parents. This was because of the last DTaP vaccine in the series.
Age: 44.0
Sex: M
Vaccine: PPV, RAB, TYP
Symptoms: Pain, Pyrexia
Clinical narrative: Aching, high fever, soreness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swelling, hot to the touch, antibiotics taken for 5 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site cellulitis, Peripheral swelling, Skin warm
Clinical narrative: The arm was swollen, red, warm and felt hard to touch.  MD diagnosed cellulitis at the injection site.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at injection site, swelling at injection site, redness at injection site, warmth at injection site.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy Hives starting under clothes area then spread to extremities and face within hours. Given Benadryl for 2 days then added prednisolone.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Back pain, Blood alkaline phosphatase increased, Chest pain, Chills
Clinical narrative: The patient is a 56 yo male with a history of CHF CRI OSA HTN who presents for adverse event evaluation after receipt of PPSV23 on 10 Jul 2015 (lot# K004487 mfx MSD) consisting of continued severe myalgias, stiffness, fatigue and weakness. He denies any symptoms of immediate hypersensitivity reaction of urticarial lesions, increased heart rate, chest pain, shortness of breath or oral/facial/throat swelling. He states he developed localized pain at the injection site within 10 minutes of vaccine receipt. He was at work and within hours developed alternating chills and "hot" flashes, nausea and fatigue. That evening his wife states he had fever of 99.9 which was treated with OTC ibuprofen. He states he felt worse the next day with notable fatigue, weakness and pain. He had localized weakness to the left arm which he had difficulty "lifting" but denies paralysis or paresis. He had generalized pain to both arms, the right being worse, right leg and low back which he describes as sharp, aching, stabbing "I felt like a bull kicked me". He states he experienced stiffness to lower extremities, especially on the left, particularly to muscles in lower legs, (R) hip, and left shoulder. He denies knee stiffness. He believes he continued fevers intermittently but did not take any temperatures. He states he developed a "knot" adjacent to the injection site (medially) which has not fully resolved but denies noting local erythema or edema. He developed chest pain and was admitted for cardiac eval on 19 Jul 2015. He was diagnosed with polymyalgia rheumatica and treated with oral prednisone and released which he states does not help. He currently continues with severe pain myalgias, weakness and stiffness and has been prescribed TYLENOL with codeine which he has taken only a few doses and feels it does not help. He states MOTRIN is effective but is concerned to take it due to his HF. He continues nausea and poor appetite and has lost approximately 8 pounds. He is activity intolerant and is unable to work. His sleep is disrupted due to pain, has difficulty turning in bed and he feels very fatigued. P: He was diagnosed with Polymyalgia Rheumatica, received oral steroid therapy which has not helped, although he experiences benefit from NSAID, but is not taking these due to CHF and CRI. His lab work demonstrates a significantly elevated ESR of 110 and an elevated RF of 18. He also demonstrated a microcytic anemia, and alk phos of 435. In chart review he also has an elevated PSA of 16 last drawn in 2013. He has a referral for rheumatology evaluation pending. His clinical history is inconsistent with a hypersensitivity reaction. His symptoms and ESR and RF factor are suggestive of a rheumatologic disorder, although he has not improved on oral steroids which is inconsistent with PMR. His symptoms are not strongly suggestive of Giant Cell Arteritis, although his ESR is concerning. The acute onset of his symptoms are inconsistent with new antibody.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Decreased activity, Decreased appetite, Fatigue, Hot flush, Impaired work ability
Clinical narrative: The patient is a 56 yo male with a history of CHF CRI OSA HTN who presents for adverse event evaluation after receipt of PPSV23 on 10 Jul 2015 (lot# K004487 mfx MSD) consisting of continued severe myalgias, stiffness, fatigue and weakness. He denies any symptoms of immediate hypersensitivity reaction of urticarial lesions, increased heart rate, chest pain, shortness of breath or oral/facial/throat swelling. He states he developed localized pain at the injection site within 10 minutes of vaccine receipt. He was at work and within hours developed alternating chills and "hot" flashes, nausea and fatigue. That evening his wife states he had fever of 99.9 which was treated with OTC ibuprofen. He states he felt worse the next day with notable fatigue, weakness and pain. He had localized weakness to the left arm which he had difficulty "lifting" but denies paralysis or paresis. He had generalized pain to both arms, the right being worse, right leg and low back which he describes as sharp, aching, stabbing "I felt like a bull kicked me". He states he experienced stiffness to lower extremities, especially on the left, particularly to muscles in lower legs, (R) hip, and left shoulder. He denies knee stiffness. He believes he continued fevers intermittently but did not take any temperatures. He states he developed a "knot" adjacent to the injection site (medially) which has not fully resolved but denies noting local erythema or edema. He developed chest pain and was admitted for cardiac eval on 19 Jul 2015. He was diagnosed with polymyalgia rheumatica and treated with oral prednisone and released which he states does not help. He currently continues with severe pain myalgias, weakness and stiffness and has been prescribed TYLENOL with codeine which he has taken only a few doses and feels it does not help. He states MOTRIN is effective but is concerned to take it due to his HF. He continues nausea and poor appetite and has lost approximately 8 pounds. He is activity intolerant and is unable to work. His sleep is disrupted due to pain, has difficulty turning in bed and he feels very fatigued. P: He was diagnosed with Polymyalgia Rheumatica, received oral steroid therapy which has not helped, although he experiences benefit from NSAID, but is not taking these due to CHF and CRI. His lab work demonstrates a significantly elevated ESR of 110 and an elevated RF of 18. He also demonstrated a microcytic anemia, and alk phos of 435. In chart review he also has an elevated PSA of 16 last drawn in 2013. He has a referral for rheumatology evaluation pending. His clinical history is inconsistent with a hypersensitivity reaction. His symptoms and ESR and RF factor are suggestive of a rheumatologic disorder, although he has not improved on oral steroids which is inconsistent with PMR. His symptoms are not strongly suggestive of Giant Cell Arteritis, although his ESR is concerning. The acute onset of his symptoms are inconsistent with new antibody.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site nodule, Injection site pain, Microcytic anaemia, Mobility decreased, Muscular weakness
Clinical narrative: The patient is a 56 yo male with a history of CHF CRI OSA HTN who presents for adverse event evaluation after receipt of PPSV23 on 10 Jul 2015 (lot# K004487 mfx MSD) consisting of continued severe myalgias, stiffness, fatigue and weakness. He denies any symptoms of immediate hypersensitivity reaction of urticarial lesions, increased heart rate, chest pain, shortness of breath or oral/facial/throat swelling. He states he developed localized pain at the injection site within 10 minutes of vaccine receipt. He was at work and within hours developed alternating chills and "hot" flashes, nausea and fatigue. That evening his wife states he had fever of 99.9 which was treated with OTC ibuprofen. He states he felt worse the next day with notable fatigue, weakness and pain. He had localized weakness to the left arm which he had difficulty "lifting" but denies paralysis or paresis. He had generalized pain to both arms, the right being worse, right leg and low back which he describes as sharp, aching, stabbing "I felt like a bull kicked me". He states he experienced stiffness to lower extremities, especially on the left, particularly to muscles in lower legs, (R) hip, and left shoulder. He denies knee stiffness. He believes he continued fevers intermittently but did not take any temperatures. He states he developed a "knot" adjacent to the injection site (medially) which has not fully resolved but denies noting local erythema or edema. He developed chest pain and was admitted for cardiac eval on 19 Jul 2015. He was diagnosed with polymyalgia rheumatica and treated with oral prednisone and released which he states does not help. He currently continues with severe pain myalgias, weakness and stiffness and has been prescribed TYLENOL with codeine which he has taken only a few doses and feels it does not help. He states MOTRIN is effective but is concerned to take it due to his HF. He continues nausea and poor appetite and has lost approximately 8 pounds. He is activity intolerant and is unable to work. His sleep is disrupted due to pain, has difficulty turning in bed and he feels very fatigued. P: He was diagnosed with Polymyalgia Rheumatica, received oral steroid therapy which has not helped, although he experiences benefit from NSAID, but is not taking these due to CHF and CRI. His lab work demonstrates a significantly elevated ESR of 110 and an elevated RF of 18. He also demonstrated a microcytic anemia, and alk phos of 435. In chart review he also has an elevated PSA of 16 last drawn in 2013. He has a referral for rheumatology evaluation pending. His clinical history is inconsistent with a hypersensitivity reaction. His symptoms and ESR and RF factor are suggestive of a rheumatologic disorder, although he has not improved on oral steroids which is inconsistent with PMR. His symptoms are not strongly suggestive of Giant Cell Arteritis, although his ESR is concerning. The acute onset of his symptoms are inconsistent with new antibody.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: The patient is a 56 yo male with a history of CHF CRI OSA HTN who presents for adverse event evaluation after receipt of PPSV23 on 10 Jul 2015 (lot# K004487 mfx MSD) consisting of continued severe myalgias, stiffness, fatigue and weakness. He denies any symptoms of immediate hypersensitivity reaction of urticarial lesions, increased heart rate, chest pain, shortness of breath or oral/facial/throat swelling. He states he developed localized pain at the injection site within 10 minutes of vaccine receipt. He was at work and within hours developed alternating chills and "hot" flashes, nausea and fatigue. That evening his wife states he had fever of 99.9 which was treated with OTC ibuprofen. He states he felt worse the next day with notable fatigue, weakness and pain. He had localized weakness to the left arm which he had difficulty "lifting" but denies paralysis or paresis. He had generalized pain to both arms, the right being worse, right leg and low back which he describes as sharp, aching, stabbing "I felt like a bull kicked me". He states he experienced stiffness to lower extremities, especially on the left, particularly to muscles in lower legs, (R) hip, and left shoulder. He denies knee stiffness. He believes he continued fevers intermittently but did not take any temperatures. He states he developed a "knot" adjacent to the injection site (medially) which has not fully resolved but denies noting local erythema or edema. He developed chest pain and was admitted for cardiac eval on 19 Jul 2015. He was diagnosed with polymyalgia rheumatica and treated with oral prednisone and released which he states does not help. He currently continues with severe pain myalgias, weakness and stiffness and has been prescribed TYLENOL with codeine which he has taken only a few doses and feels it does not help. He states MOTRIN is effective but is concerned to take it due to his HF. He continues nausea and poor appetite and has lost approximately 8 pounds. He is activity intolerant and is unable to work. His sleep is disrupted due to pain, has difficulty turning in bed and he feels very fatigued. P: He was diagnosed with Polymyalgia Rheumatica, received oral steroid therapy which has not helped, although he experiences benefit from NSAID, but is not taking these due to CHF and CRI. His lab work demonstrates a significantly elevated ESR of 110 and an elevated RF of 18. He also demonstrated a microcytic anemia, and alk phos of 435. In chart review he also has an elevated PSA of 16 last drawn in 2013. He has a referral for rheumatology evaluation pending. His clinical history is inconsistent with a hypersensitivity reaction. His symptoms and ESR and RF factor are suggestive of a rheumatologic disorder, although he has not improved on oral steroids which is inconsistent with PMR. His symptoms are not strongly suggestive of Giant Cell Arteritis, although his ESR is concerning. The acute onset of his symptoms are inconsistent with new antibody.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Prostatic specific antigen increased, Pyrexia, Red blood cell sedimentation rate increased, Rheumatic disorder, Rheumatoid factor positive
Clinical narrative: The patient is a 56 yo male with a history of CHF CRI OSA HTN who presents for adverse event evaluation after receipt of PPSV23 on 10 Jul 2015 (lot# K004487 mfx MSD) consisting of continued severe myalgias, stiffness, fatigue and weakness. He denies any symptoms of immediate hypersensitivity reaction of urticarial lesions, increased heart rate, chest pain, shortness of breath or oral/facial/throat swelling. He states he developed localized pain at the injection site within 10 minutes of vaccine receipt. He was at work and within hours developed alternating chills and "hot" flashes, nausea and fatigue. That evening his wife states he had fever of 99.9 which was treated with OTC ibuprofen. He states he felt worse the next day with notable fatigue, weakness and pain. He had localized weakness to the left arm which he had difficulty "lifting" but denies paralysis or paresis. He had generalized pain to both arms, the right being worse, right leg and low back which he describes as sharp, aching, stabbing "I felt like a bull kicked me". He states he experienced stiffness to lower extremities, especially on the left, particularly to muscles in lower legs, (R) hip, and left shoulder. He denies knee stiffness. He believes he continued fevers intermittently but did not take any temperatures. He states he developed a "knot" adjacent to the injection site (medially) which has not fully resolved but denies noting local erythema or edema. He developed chest pain and was admitted for cardiac eval on 19 Jul 2015. He was diagnosed with polymyalgia rheumatica and treated with oral prednisone and released which he states does not help. He currently continues with severe pain myalgias, weakness and stiffness and has been prescribed TYLENOL with codeine which he has taken only a few doses and feels it does not help. He states MOTRIN is effective but is concerned to take it due to his HF. He continues nausea and poor appetite and has lost approximately 8 pounds. He is activity intolerant and is unable to work. His sleep is disrupted due to pain, has difficulty turning in bed and he feels very fatigued. P: He was diagnosed with Polymyalgia Rheumatica, received oral steroid therapy which has not helped, although he experiences benefit from NSAID, but is not taking these due to CHF and CRI. His lab work demonstrates a significantly elevated ESR of 110 and an elevated RF of 18. He also demonstrated a microcytic anemia, and alk phos of 435. In chart review he also has an elevated PSA of 16 last drawn in 2013. He has a referral for rheumatology evaluation pending. His clinical history is inconsistent with a hypersensitivity reaction. His symptoms and ESR and RF factor are suggestive of a rheumatologic disorder, although he has not improved on oral steroids which is inconsistent with PMR. His symptoms are not strongly suggestive of Giant Cell Arteritis, although his ESR is concerning. The acute onset of his symptoms are inconsistent with new antibody.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Sleep disorder, Weight decreased
Clinical narrative: The patient is a 56 yo male with a history of CHF CRI OSA HTN who presents for adverse event evaluation after receipt of PPSV23 on 10 Jul 2015 (lot# K004487 mfx MSD) consisting of continued severe myalgias, stiffness, fatigue and weakness. He denies any symptoms of immediate hypersensitivity reaction of urticarial lesions, increased heart rate, chest pain, shortness of breath or oral/facial/throat swelling. He states he developed localized pain at the injection site within 10 minutes of vaccine receipt. He was at work and within hours developed alternating chills and "hot" flashes, nausea and fatigue. That evening his wife states he had fever of 99.9 which was treated with OTC ibuprofen. He states he felt worse the next day with notable fatigue, weakness and pain. He had localized weakness to the left arm which he had difficulty "lifting" but denies paralysis or paresis. He had generalized pain to both arms, the right being worse, right leg and low back which he describes as sharp, aching, stabbing "I felt like a bull kicked me". He states he experienced stiffness to lower extremities, especially on the left, particularly to muscles in lower legs, (R) hip, and left shoulder. He denies knee stiffness. He believes he continued fevers intermittently but did not take any temperatures. He states he developed a "knot" adjacent to the injection site (medially) which has not fully resolved but denies noting local erythema or edema. He developed chest pain and was admitted for cardiac eval on 19 Jul 2015. He was diagnosed with polymyalgia rheumatica and treated with oral prednisone and released which he states does not help. He currently continues with severe pain myalgias, weakness and stiffness and has been prescribed TYLENOL with codeine which he has taken only a few doses and feels it does not help. He states MOTRIN is effective but is concerned to take it due to his HF. He continues nausea and poor appetite and has lost approximately 8 pounds. He is activity intolerant and is unable to work. His sleep is disrupted due to pain, has difficulty turning in bed and he feels very fatigued. P: He was diagnosed with Polymyalgia Rheumatica, received oral steroid therapy which has not helped, although he experiences benefit from NSAID, but is not taking these due to CHF and CRI. His lab work demonstrates a significantly elevated ESR of 110 and an elevated RF of 18. He also demonstrated a microcytic anemia, and alk phos of 435. In chart review he also has an elevated PSA of 16 last drawn in 2013. He has a referral for rheumatology evaluation pending. His clinical history is inconsistent with a hypersensitivity reaction. His symptoms and ESR and RF factor are suggestive of a rheumatologic disorder, although he has not improved on oral steroids which is inconsistent with PMR. His symptoms are not strongly suggestive of Giant Cell Arteritis, although his ESR is concerning. The acute onset of his symptoms are inconsistent with new antibody.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood sodium normal, Chest X-ray normal, Electroencephalogram normal, Mycobacterium test positive, Protein urine present
Clinical narrative: Seizures. Fever.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Seizures. Fever.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Flushing, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Initial report was received from a healthcare professional on 18 October 2012. The reporter for this case is the same as for case number 2012-09898. An unknown patient (age, gender and birth date not reported) received an intradermal injection of FLUZONE Intradermal, sanofi pasteur Inc., lot number UT4470AA (site and side not reported) on 18 October 2012. On 18 October 2012, within a few minutes after the vaccination, the patient experienced chest tightness and diaphoresis and had to go to the emergency room due to anaphylactic reaction. The patient also experienced numbness and tingling on the roof of the mouth, severe vertigo, flushing and shortness of breath. The patient was observed in the emergency room for one half hour and then the patient was discharged when symptoms subsided. The patient's medical conditions and illness at time of vaccination was reported as unknown. The patient had no allergies and had received flu vaccine in the past. The patient's outcome was reported as unknown. Follow-up information received from a healthcare professional on 19 October 2012. Based upon the new information provided, this case has been downgraded to non-serious. The patient was 56-years-old. As information was provided for both cases (cluster), the individual patient's history was not able to be determined. One of the two patients had a penicillin (PCN) allergy and the other patient had no allergies. Neither patient had a food allergy or history of anxiety disorder. Both patients had received intramuscular influenza vaccines in the past without incident. Both patients had tightness of chest and diaphoresis. One of the two patients experienced flushing and "throat tingling". Both patients were observed in the emergency room (ER); no epinephrine or antihistamine was administered. The patient was discharged from the ER after one half hour observation when symptoms subsided. Based on follow-up information, the events of anaphylactic reaction, shortness of breath, vertigo CNS origin and numbness mouth were removed from MedDRA coding. The patient's outcome was reported as recovered on 18 October 2012. Documents held by sender: None. Follow-up information was received on 06 November 2012. This case is cluster with 2012-09898 and 2012-10407 same reporter and same lot number. The patient's age 55 years and gender female. The previously reported events diaphoresis and tingling roof of mouth were no more reported in the follow-up. Immediately after vaccination on 18 October 2012, the patient had lightheaded feeling, flushing and chest tightness. The patient visited the emergency department. Within half an hour, the events felt lightheaded, flushing and chest tightness had resolved. The patient did not receive any treatment in the emergency department.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K018959, expiration date 15-OCt-2016, dose and frequency were not reported), which was improperly stored. No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K018959, expiration date 15-OCT-2016, dose and frequency were not reported), which was improperly stored (Incorrect product storage). No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no information about the patient's concurrent condition, medical history and concomitant therapy. On 31-JUL-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (strength, route and dose unknown, lot # K024036, expiration date: 26-NOV-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K018959, expiration date 15-OCT-2016, dose and frequency were not reported), which was improperly stored(Incorrect product storage). No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K018959, expiration date 15-OCT-2015, dose and frequency were not reported), which was improperly stored. No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown dates, unspecified patients were vaccinated with improperly stored doses of GARDASIL (lot # K016966, 10-MAY-2017 and Lot # K023432, expiration date: 18-JUN-2016) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. On 23-JUL-2015, the healthcare worker called to report a temperature excursion. The original caller, did not have relevant information regarding the excursion. The nurse who was called back with additional information on the same day and reported the lots # and expiration dates and the use of improperly stored vaccines. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-NOV-2012 and 18-JUN-2013, the patient was vaccinated with the first and second dose of VAQTA (lot numbers, expiration dates and doses not reported) intramuscularly, respectively. On 22-JUL-2015 the patient was inadvertently administered a third dose of VAQTA lot # K018181, expiration date 04-JUN-2017, intramuscularly (dose not reported) (Extra dose administered). No adverse effects were reported. Additional information has been requested.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 16 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unspecified date, the patients were vaccinated with an improperly stored PROQUAD (Merck), (route of administration was not reported), (lot # K025761, expiry date 08-JUN-2016). At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source,. Additional information has been requested.
Age: 1.29
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15m months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.66
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 20 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.39
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 16 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.29
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored dose of the PNEUMOVAX 23 (dose, site, route of administration, lot# and expiry date were not reported). was administered to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 2 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L006386, expiration date 25-FEB-2016, dose and frequency were not reported), which was improperly stored(Incorrect product storage). No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # K020181, expiration date 24-JUN-2015 (strength and dose were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as there was no consent to contact any physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K015969, expiration date 23-SEP-2016, dose and frequency were not reported), which was improperly stored. No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.