chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, MEN, TDAP, VARCEL
Symptoms: Blood glucose normal, Electrocardiogram normal, Immediate post-injection reaction, Syncope
Clinical narrative: Pt received 5 vaccinations (Hep A, Hep B, Varicella, Meningococcal, and TdaP). Immediately after injection, pt had syncopal episode. Was responsive and oriented to place and time following being placed in supine position, but continued to close eyes immediately after stimulus for several minutes following injections. VS were normal. Exam normal. Pt placed in Trendelenburg position and given IV fluids. Glucose level 73. ECG normal. Orthostatic BPs normal. EMS responded, but parent refused transport. Pt eventually returned to normal.
Age: 51.0
Sex: M
Vaccine: JEV1
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: MACUOLOPAPULAR RASH, STARTED ON LEFT ARM (SAME ARM AS INJECTION SITE, BUT MORE DISTAL) AND SPREAD TO RIGHT ARM, NECK, BACK, TRUNK, THIGHS.  ONSET TIME WAS THE EVENING AFTER RECEIVING IT (HOURS).  RASH MILDLY PRURITIC.  NO SYSTEMIC SYMPTOMS.  ANTIHISTAMINES PRESCRIBED.  PATIENT ADVISED TO CALL IF RASH OR SYMPTOMS WORSEN.
Age: 1.2
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Swelling by the ear lobe and fever. Later the lymph node by the ear lobe hardened and the fever came only at night for about 4 to 5 nights. The swollen lymph node still exist after 10 days on onset.
Age: 17.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Dizziness, Headache
Clinical narrative: Waxing and waning headache and dizziness for a week after administration.  Seen in office 4 days later.  Afebrile, not orthostatic, normal vitals and exam.  Treated conservatively with NSAID. Can fax note, if desired.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Hand sized diffuse red rash around injection site, patient reported mild itching in addition to the redness. No other symptoms reported, patient declined further medical follow up.  She was instructed to take Diphenhydramine 25mg that evening to assist with redness and itch.
Age: 1.02
Sex: M
Vaccine: MMR, UNK
Symptoms: Blister, Irritability, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Fever, rash, blister like lesions.  Irritable, sore throat, puffy face.
Age: 1.02
Sex: M
Vaccine: MMR, UNK
Symptoms: Swelling face, Vaccination complication, White blood cell count normal
Clinical narrative: Fever, rash, blister like lesions.  Irritable, sore throat, puffy face.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Humerus fracture, Hypertrophic osteoarthropathy, Immediate post-injection reaction, Joint effusion, Musculoskeletal pain
Clinical narrative: I have had continual pain in my shoulder from the moment of the vaccine to present. There was a brief break from pain only when I was using oral steroids for my asthma. Since then I have been through physical therapy, which was unsuccessful. Next I was sent for an MRI, which showed a serious shoulder injury. The injury included liquid in my joint, as if I had received therapeutic injections, though I had received no injection but the flu shot. It also showed a torn rotator cuff, possible swelling of the bone marrow, the muscle pulling away from the bone, and a possible Hills-Sachs injury, though I had never previously dislocated my shoulder. Prior to this flu shot, I had never had any pain in my shoulder. I am now being told that I will need to have surgery.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Synovitis, Tendon disorder, Tendonitis
Clinical narrative: I have had continual pain in my shoulder from the moment of the vaccine to present. There was a brief break from pain only when I was using oral steroids for my asthma. Since then I have been through physical therapy, which was unsuccessful. Next I was sent for an MRI, which showed a serious shoulder injury. The injury included liquid in my joint, as if I had received therapeutic injections, though I had received no injection but the flu shot. It also showed a torn rotator cuff, possible swelling of the bone marrow, the muscle pulling away from the bone, and a possible Hills-Sachs injury, though I had never previously dislocated my shoulder. Prior to this flu shot, I had never had any pain in my shoulder. I am now being told that I will need to have surgery.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: I have had continual pain in my shoulder from the moment of the vaccine to present. There was a brief break from pain only when I was using oral steroids for my asthma. Since then I have been through physical therapy, which was unsuccessful. Next I was sent for an MRI, which showed a serious shoulder injury. The injury included liquid in my joint, as if I had received therapeutic injections, though I had received no injection but the flu shot. It also showed a torn rotator cuff, possible swelling of the bone marrow, the muscle pulling away from the bone, and a possible Hills-Sachs injury, though I had never previously dislocated my shoulder. Prior to this flu shot, I had never had any pain in my shoulder. I am now being told that I will need to have surgery.
Age: 16.0
Sex: F
Vaccine: HEPA, MEN, TDAP, VARCEL
Symptoms: Dizziness, Ear discomfort, Feeling hot, Pallor, Syncope
Clinical narrative: Fainting- patient reports feeling hot, feeling like her ears were going to pop, dizzy & lightheaded.   She was observed to lose all color in her face and was immediately assisted to a bench to lay down.
Age: 1.63
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site mass, Weight bearing difficulty, X-ray limb normal
Clinical narrative: Toddler became unable to put any pressure on leg that injection was administered in.  Took. Hold to ER where an X-ray was done and any injury was ruled out. There was still. So sable knot in the leg where injection site was. Doctor determined treatment to be Motrin and heating pad on lump at injection site. This seems to be working.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure decreased, Pallor, Vomiting
Clinical narrative: Five minutes after receiving these 2 immunizations patient vomited, had decreased BP from 134/82 to 99/57, became pale. Symptoms resolved within one hour and patient discharged home with father.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Allergy test, Blood immunoglobulin E, Urticaria
Clinical narrative: Pt developed hives that night after receiving vaccines.
Age: 66.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Lymphadenopathy, Muscle spasms, Oedema peripheral, Pain, Pruritus
Clinical narrative: See VAERS report # E-59409. On eve of 1-10-12 cough began by 1-13-12 morning of I went into urgent care test were ran diagnosed with pneumonia.
Age: 66.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Rash erythematous, Skin warm
Clinical narrative: See VAERS report # E-59409. On eve of 1-10-12 cough began by 1-13-12 morning of I went into urgent care test were ran diagnosed with pneumonia.
Age: 66.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Cough, Laboratory test abnormal, Pneumonia
Clinical narrative: See VAERS report # E-59409. On eve of 1-10-12 cough began by 1-13-12 morning of I went into urgent care test were ran diagnosed with pneumonia.
Age: 40.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: HEADACHE, NAUSEA, DIZZINESS.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Blood immunoglobulin E normal, Erythema, Histamine level, Hypersensitivity, Irritability
Clinical narrative: One small hive appeared on lower back and did not grow or change throughout the day.  Woke up next morning 2/6/12 with dozens of hives on various parts of body (back, legs, arms).  Had minor reaction the day of the immunization - localized swelling, redness, and irritability and then no adverse signs until six days later.  In 2011, major hives breakout 14 days after HepA immunization, so suspect allergic reaction to the vaccines.  Pediatrician disagrees.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Local swelling, Urticaria
Clinical narrative: One small hive appeared on lower back and did not grow or change throughout the day.  Woke up next morning 2/6/12 with dozens of hives on various parts of body (back, legs, arms).  Had minor reaction the day of the immunization - localized swelling, redness, and irritability and then no adverse signs until six days later.  In 2011, major hives breakout 14 days after HepA immunization, so suspect allergic reaction to the vaccines.  Pediatrician disagrees.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Pt given PENTACEL combo and given 2nd Hib dose.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Administration error. A 63 year old male received 0.5 mL of Td intradermally instead of a PPD, on 02/14/11. The patient developed redness, swelling, pain and warmth at the injection site, immediately after receiving the vaccine. The patient was advised to treat the symptoms with an ice pack. Patient also received a PPD on the same day. Patient recovered by 02/18/11.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Injection site warmth, Wrong drug administered
Clinical narrative: Administration error. A 63 year old male received 0.5 mL of Td intradermally instead of a PPD, on 02/14/11. The patient developed redness, swelling, pain and warmth at the injection site, immediately after receiving the vaccine. The patient was advised to treat the symptoms with an ice pack. Patient also received a PPD on the same day. Patient recovered by 02/18/11.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Flare up rash on L. thigh. Slightly puffy.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: Hyperhidrosis, Joint swelling, Mobility decreased, Oedema peripheral, Pain
Clinical narrative: Vaccine given 10/11/11, s/sx pain sweating, no fever, swelling in legs, wrists, knees not related to previous hip injury decreased mobility ER visit 12/26/11, x-rays taken, 1/3/12 F/U visit to dr.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: X-ray
Clinical narrative: Vaccine given 10/11/11, s/sx pain sweating, no fever, swelling in legs, wrists, knees not related to previous hip injury decreased mobility ER visit 12/26/11, x-rays taken, 1/3/12 F/U visit to dr.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: Arthralgia, Arthritis, Asthenia, Guillain-Barre syndrome, Hip fracture
Clinical narrative: Vaccine given 10/11/11, s/sx pain sweating, no fever, swelling in legs, wrists, knees not related to previous hip injury decreased mobility ER visit 12/26/11, x-rays taken, 1/3/12 F/U visit to dr.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: Hyperhidrosis, Mobility decreased, Pain in extremity, Walking aid user, X-ray
Clinical narrative: Vaccine given 10/11/11, s/sx pain sweating, no fever, swelling in legs, wrists, knees not related to previous hip injury decreased mobility ER visit 12/26/11, x-rays taken, 1/3/12 F/U visit to dr.
Age: 1.8
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism, Pyrexia, Rash generalised, Vomiting
Clinical narrative: Information has been received from a mother concerning her 22 month old son with allergy to corn, turkey, soy, dairy, sesame, eggs, chicken, watermelon, tree nuts, peanuts, onions, garlic, shellfish and fish and a history of immunocompromised who in approximately December 2007, was vaccinated with a dose of MMR II, (dose, route and lot number not reported). On an unknown date, the patient developed a high fever with spots over his body, accompanied by vomiting ("through up for days"). The mother reported that her son lost his speech and developed autism after vaccination with the MMR II and had not completely recovered at the time of the report. The patient sought medical attention, contacted the physician. Lost speech was considered to be an other important medical event. The patient also had a history of stopped breathing and respiratory infection while on therapy with influenza virus split virion 3V vaccine inactivated, (WAES # 1202USA00716). No further information is available.
Age: 54.0
Sex: U
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Was given flu shot high on left arm. It became very sore & then I was unable to move it and it effected the deltoid muscle.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pruritus, Rash erythematous, Skin warm, Tenderness
Clinical narrative: 11cm x 11cm oval red rash, itching, tender to touch, warm to touch. Tx - ORAPRED 15mg/5 ml - 1 tsp BID x 5 days, OTC cortisone cephalexin 25mg/5m - 2 tsp BID x 10days.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Diarrhoea, Injection site swelling, Local reaction
Clinical narrative: Baby received vaccines on 1/27/12 at 1:11 pm. Parents brought child to ER same night (8pm) for crying uncontrollably. Swelling (R) thigh. Diarrhea since received vaccines. Local reaction. Received KEFLEX x 7 days. Baby better possible reaction to PENTACEL.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt stated that left arm started to hurt about two hours after injection. Pt is having difficulty raising left arm. Pt was given an rx for ibuprofen by Dr.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Weight bearing difficulty
Clinical narrative: Pt was given vaccine by Dr. nurse 2-2-12 was seen in our clinic 2-3-12 with (R) leg swollen, red, hot, fever and unable to bear weight.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Pain, Rash papular, Swelling
Clinical narrative: Pt received a ZOSTAVAX vaccine on 2/1/12 SQ in his (L) arm. Next day noted pain, swelling and papular/vesicular rash within an approximately 7 cm diameter area of erythema. Pain scale 5/10. Temp on 2/3/12 99.2.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Pain in extremity, Skin plaque, Tenderness
Clinical narrative: Patient called 2/3/12 has rash (L) deltoid left arm bicep anterior and axillary irregular shaped erythematous plaque of varying sizes non blanching (+) tender - no adenopathy & painful arm.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness - size of small grapefruit at injection site.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Activities of daily living impaired, Headache, Loss of consciousness, Malaise, Pain
Clinical narrative: PT reports the HM administered smallpox vaccine on the left arm in 3 locations; re-applying vaccine to the needle on each occasion. He was unable to do "take check one week later" and further states that he was unable to do anything for 3 days as a result of fever, general malaise, body aches, headaches; he does not recall that timeframe stating "I was unconscious for 3 days but was unable to go to hospital because my roomate was out of town".
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia
Clinical narrative: PT reports the HM administered smallpox vaccine on the left arm in 3 locations; re-applying vaccine to the needle on each occasion. He was unable to do "take check one week later" and further states that he was unable to do anything for 3 days as a result of fever, general malaise, body aches, headaches; he does not recall that timeframe stating "I was unconscious for 3 days but was unable to go to hospital because my roomate was out of town".
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Aches, fever, sweats, stiffness that night. Within two days he had polyarthralgias which responded to steroids. Now he still has arthralgias of hands, wrists and shoulders with new symptoms in knees.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Aches, fever, sweats, stiffness that night. Within two days he had polyarthralgias which responded to steroids. Now he still has arthralgias of hands, wrists and shoulders with new symptoms in knees.
Sex: F
Vaccine: HEP, TD
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Administration error. A female patient received Td vaccine intradermally instead of a PPD, on 05/16/11. The day after the injection, she experienced redness and swelling at the injection site. The condition worsened two days after the injection and the patient was advised to go to the emergency room. Follow up obtained on 06/01/11: Patient went to the emergency room on 5/18/11 and was prescribed antibiotic, KEFLEX 500 mg, twice/day. Patient recovered.
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity
Clinical narrative: A female patient had an allergic reaction to a tetanus/diphtheria vaccine. This event was reported to MBL's distributor, Merck, by a pharmacist. MBL contacted the pharmacist; no further information was available about this event, including specifics about the allergic reaction, product manufacturer or the time when the event occurred. MBL is not able to obtain any further follow-up information.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: Redness, swelling, tingling, pain in her right upper arm.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Headache, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of 2 day fever, headache, joint pain, arm pain & redness at injection site.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness to deltoid area - increasing in size. Now about 3cm x 3cm. Positive warmth no tenderness positive itch initially.
Sex: M
Vaccine: MEA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with ATTENUVAX (manufacturer unknown, lot # not provided). On an unspecified date after administered ATTENUVAX (manufacturer unknown) the patient developed a fever. Whether the patient sought medical attention was not reported. The patient's outcome was unknown. The patient subsequently experienced a fever after administration of MMR II (WAES 1109USA00597). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Diffuse macular papular rash over axilla (left). Persisted for 5 days. No vesicles. (+) pruritus. No respiratory distress or stridor.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Dysstasia, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Could not walk or stand June 19, 2010, diagnosed Guillain-Barre Syndrome. IVIG given as treatment had reaction almost died. Recurred Nov 4 IVIG given 21 days in rehab. This has changed my life & my marriage. I can't do any kind of work & don't feel like being a companion to my husband. This is a very bad sickness, I have been fighting it a long time. I had it 2 times & could have it again. I don't think I will ever be the same.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Quality of life decreased
Clinical narrative: Could not walk or stand June 19, 2010, diagnosed Guillain-Barre Syndrome. IVIG given as treatment had reaction almost died. Recurred Nov 4 IVIG given 21 days in rehab. This has changed my life & my marriage. I can't do any kind of work & don't feel like being a companion to my husband. This is a very bad sickness, I have been fighting it a long time. I had it 2 times & could have it again. I don't think I will ever be the same.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pyrexia, Rhinitis, Upper respiratory tract infection
Clinical narrative: Cough & rhinitis started 4 days after flu vaccine. Reported fever up to 101. Seen in office 12/27/11, temp 97.4. Diagnosed with URI.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports swelling and redness present at injection site.  Hot to the touch.  Application of cold has helped symptoms.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Computerised tomogram head, Computerised tomogram normal, Febrile convulsion, Influenza A virus test negative, Influenza B virus test
Clinical narrative: FEBRILE SEIZURE.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Influenza virus test negative, Respiratory syncytial virus test negative, Streptococcus test negative
Clinical narrative: FEBRILE SEIZURE.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient received a TDAP injection on 1/20/12 at approx. 2:30 PM. According to her daughter, patient began to have swelling and pain at the site of injection on Saturday, 1/21/12. A rash also began to appear at the site that same day. Patient went to the doctor's office on Thursday, 1/26/12. The doctor performed a visual inspection of the site and gave her a prescription for antibiotics due to possible infection. Patient stated that the office did not do any lab work and she never took her temperature, but occasionally felt warm. As of 2/9/12 the medications have helped "a little bit", but patient still has pain at the site of injection and the area is warm to the touch. Patient's husband received the TDAP vaccine on the same day with no reactions.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Unevaluable event
Clinical narrative: xx
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Headache - persisting for 2 week.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash
Clinical narrative: Rash with itching.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Laboratory test normal, Urine analysis normal
Clinical narrative: 2/1/12 11pm seizure #1 no fever lasted approx 2 min, to medical center exam WNL, DC home. 2/2/12 5am seizure #2 temp 99.7 Ax lasted approx 2 min, to medical center exam WNL. Admitted for observation Chem 14, UA WNL. 2/8/12 seizure #3 1210pm unsure how many min, to medical center exam WNL. Referred to neurologist for evaluation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination site erythema, Vaccination site oedema
Clinical narrative: Erythema & edema at site of vaccination 3 x 4 cm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site cellulitis, Staphylococcal infection
Clinical narrative: Patient seen by dr on 1/15/12 for (L) deltoid cellulitis (arm, erythemic patch), probably MRSA - treated with BACTRIM DS. - Post PPV.
Age: 49.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site joint pain, Injection site joint swelling, Injection site joint warmth, Injection site reaction, Joint stiffness
Clinical narrative: Vaccine reaction (L) shoulder post PPV (pain, warmth, swelling & tight). Treated with TYLENOL # 3) Ibuprofen & ice compress
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling & erythema.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Anion gap increased, Aspartate aminotransferase increased, Basophil percentage decreased, Bilirubin conjugated
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride decreased
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatinine increased, Blood glucose increased, Blood magnesium decreased, Blood phosphorus, Blood potassium decreased
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blood sodium decreased, Blood urea increased, Blood urea nitrogen/creatinine ratio, Carbon dioxide decreased, Death
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eosinophil percentage decreased, Feeling cold, Globulins increased, Granulocyte percentage, Haematocrit normal
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Haemoglobin normal, Immunoglobulins, Laboratory test, Livedo reticularis, Lymphocyte percentage decreased
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume increased, Monocyte percentage
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased, Protein total decreased, Protein total normal, Pulse absent, Red blood cell count normal
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Red cell distribution width increased, Respiratory arrest, Resuscitation, White blood cell count increased
Clinical narrative: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt states she has a 'hive' 1" x 2", 1.5" below injection site. The hive appeared 4-5 days post injection. It is sore. No fever, dizziness, SOB reported.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Received varicella vaccine 1/24/12. Seen in campus Health for rash. Referred to optometrist. Seen in ER for vomiting, nausea. Seen in Primary care for examination of lesions. F/U by optometrist for F/U on 2/10/12. F/U by Primary care on 2/14/12.
Age: 1.01
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Bronchiolitis, Measles, Measles antibody positive, Rash, Upper respiratory tract infection
Clinical narrative: Atypical measles. Initially patient had severe URI/bronchiolitis symptoms for 2 weeks following vaccinations. Then broke out in rash consistent with measles on 01-16-12.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity, X-ray abnormal
Clinical narrative: School nurse reported that patient had complained of arm hurting after receiving flu vaccine at school clinic. Patient told school nurse a few weeks ago that her arm still hurt and she couldn't raise her arm without pain.  Patient went to see her doctor and was given an x-ray. Dr. told patient that shot was given "too high".
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chest pain, Heart rate increased, Malaise, Pyrexia
Clinical narrative: I received a call from this associate telling me the complications that she had since her Tdap was given on 1/19/2012. She said the day of the shot she left early because of a fever, and malaise. After she got home she noticed that she was having hives, chest pain and increased heart rate. She said she began to take Benadryl and Ibuprofen/Tylenol. She called into work sick and stayed in bed. Today when I talked to her she said she was still taking the Ibuprofen/Tylenol and that she did not have any more s/s of chest pain, increased heart rate, or hives. She did not know what her temperature was but she did not feel feverish. I advised her to call me if there were any changes and recommended that she go to the ER if she had any more issues with chest pain, increased heart rate or hives.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: I received a call from this associate telling me the complications that she had since her Tdap was given on 1/19/2012. She said the day of the shot she left early because of a fever, and malaise. After she got home she noticed that she was having hives, chest pain and increased heart rate. She said she began to take Benadryl and Ibuprofen/Tylenol. She called into work sick and stayed in bed. Today when I talked to her she said she was still taking the Ibuprofen/Tylenol and that she did not have any more s/s of chest pain, increased heart rate, or hives. She did not know what her temperature was but she did not feel feverish. I advised her to call me if there were any changes and recommended that she go to the ER if she had any more issues with chest pain, increased heart rate or hives.
Age: 0.26
Sex: M
Vaccine: HIBV, PNC
Symptoms: Body temperature increased, Discomfort, Irritability, Pallor, Vomiting projectile
Clinical narrative: My son projectile vomited 2 times at this time and had a small temp of around 99.3 for a few hours after throwing up. My son was very fussy and uncomfortable. He was also very pale after throwing up.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rash papular, Skin warm
Clinical narrative: Red rash, hot to touch, raised surface.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Hot itchy, swollen red hives in all skin areas where there is pressure from clothes.
Age: 36.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, TDAP, VARCEL
Symptoms: Blister, Burning sensation, Erythema
Clinical narrative: Patient complained of Left Breast redness, blisters, burning.  She has a history of a Left breast implant.
Age: 0.22
Sex: F
Vaccine: HEP, PNC, RV5
Symptoms: Immediate post-injection reaction, Vomiting projectile
Clinical narrative: Immediate projectile vomiting both times immunization was administered 1/23/12 and 2-09-12.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen under left armpit, tender under left armpit, headache.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Back pain, Balance disorder
Clinical narrative: 12 hrs after vaccination (3:00 a.m. 2/8/12) - chills, fever, entire body pain - joints, back, face, ears, throat "sinus headache over 1/2 face"; knee pain, ankle pain, eye ache, outer ear pain. Continuous until 2/1/12 afternoon. Required 24 tx. TYLENOL & ALEVE rx. 2/9/12 - lethargy, weakness, knees fell wobbly; dizziness, could not attend class x 2 days due to extreme symptoms.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Dizziness, Ear pain, External ear pain, Eye pain
Clinical narrative: 12 hrs after vaccination (3:00 a.m. 2/8/12) - chills, fever, entire body pain - joints, back, face, ears, throat "sinus headache over 1/2 face"; knee pain, ankle pain, eye ache, outer ear pain. Continuous until 2/1/12 afternoon. Required 24 tx. TYLENOL & ALEVE rx. 2/9/12 - lethargy, weakness, knees fell wobbly; dizziness, could not attend class x 2 days due to extreme symptoms.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Facial pain, Lethargy, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 12 hrs after vaccination (3:00 a.m. 2/8/12) - chills, fever, entire body pain - joints, back, face, ears, throat "sinus headache over 1/2 face"; knee pain, ankle pain, eye ache, outer ear pain. Continuous until 2/1/12 afternoon. Required 24 tx. TYLENOL & ALEVE rx. 2/9/12 - lethargy, weakness, knees fell wobbly; dizziness, could not attend class x 2 days due to extreme symptoms.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Sinus headache
Clinical narrative: 12 hrs after vaccination (3:00 a.m. 2/8/12) - chills, fever, entire body pain - joints, back, face, ears, throat "sinus headache over 1/2 face"; knee pain, ankle pain, eye ache, outer ear pain. Continuous until 2/1/12 afternoon. Required 24 tx. TYLENOL & ALEVE rx. 2/9/12 - lethargy, weakness, knees fell wobbly; dizziness, could not attend class x 2 days due to extreme symptoms.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to vaccine (R) shoulder.
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a male patient who on unknown date (also reported as "a couple years ago"), was "possibly" vaccinated with the first dose of ROTATEQ (lot number, dose and route not reported) and developed intussusception. The patient had to undergo surgery at an unspecified location. The patient's outcome was recovered at the time of report (also reported as "the patient did well after the surgery"). Upon internal review the adverse event was determined to be an other important medical event. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Initial report received on 01 February 2012 from another manufacturer, report # WAES1201USA00639. The initial reporter to this manufacturer had been a health care professional. The following was verbatim from another manufacturer, report #WAES 1201USA00639: "Information has been received from a Registered Pharmacist (P.Ph.) concerning a 68 year old male patient with no pertinent medical history and no drug reactions who on 23 December 2011 was vaccinated intramuscular in left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot#669579/0595AA, exp. 30 August 2012). There was no concomitant medications. On 05 January 2012 the patient call to the pharmacist and said that he could not lift his left arm in which the injection was given. At the time of the report the patient's status was not recovered. Additional information has been received from Registered Pharmacist (R.P.) and Licensed Visiting Nurse (V.L.N.) concerning a 68 year old male patient with diabetes mellitus (type unspecified), hypertension and allergy to codeine and morphine who on 23 December 2011 was vaccinated intramuscular in left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot#669579/595AA, exp. 30 August 2012). Secondary suspect included FLUZONE administered on 23 December 2011, in right arm (dose, route unknown), (Lot#UH477AB). It was reported that patient was in clinic on 13 January 2012, with complaints of right shoulder pain, discomfort in left shoulder, intermittent tingling and cramps of the hands. The Licensed Visiting Nurse (V.L.N.) reported that patient stated his events were due to the PNEUMOVAX 23 and FLUZONE he received in December 2011. On 13 January 2012 the patient underwent an X-ray of the right shoulder which showed arthritis with no bone injury identified and no muscle wasting; diagnosis; osteoarthritis; rotator cuff tendonitis and radiculopathy. The patient was told continue range of motion and to follow-up with physician after MRI was performed (this had not happened as of 26 January 2012). At the time of the report the patient status was unknown. No further information is available." Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Arthritis, Injected limb mobility decreased, Injection site discomfort, Injection site joint pain, Muscle spasms
Clinical narrative: Initial report received on 01 February 2012 from another manufacturer, report # WAES1201USA00639. The initial reporter to this manufacturer had been a health care professional. The following was verbatim from another manufacturer, report #WAES 1201USA00639: "Information has been received from a Registered Pharmacist (P.Ph.) concerning a 68 year old male patient with no pertinent medical history and no drug reactions who on 23 December 2011 was vaccinated intramuscular in left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot#669579/0595AA, exp. 30 August 2012). There was no concomitant medications. On 05 January 2012 the patient call to the pharmacist and said that he could not lift his left arm in which the injection was given. At the time of the report the patient's status was not recovered. Additional information has been received from Registered Pharmacist (R.P.) and Licensed Visiting Nurse (V.L.N.) concerning a 68 year old male patient with diabetes mellitus (type unspecified), hypertension and allergy to codeine and morphine who on 23 December 2011 was vaccinated intramuscular in left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot#669579/595AA, exp. 30 August 2012). Secondary suspect included FLUZONE administered on 23 December 2011, in right arm (dose, route unknown), (Lot#UH477AB). It was reported that patient was in clinic on 13 January 2012, with complaints of right shoulder pain, discomfort in left shoulder, intermittent tingling and cramps of the hands. The Licensed Visiting Nurse (V.L.N.) reported that patient stated his events were due to the PNEUMOVAX 23 and FLUZONE he received in December 2011. On 13 January 2012 the patient underwent an X-ray of the right shoulder which showed arthritis with no bone injury identified and no muscle wasting; diagnosis; osteoarthritis; rotator cuff tendonitis and radiculopathy. The patient was told continue range of motion and to follow-up with physician after MRI was performed (this had not happened as of 26 January 2012). At the time of the report the patient status was unknown. No further information is available." Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Osteoarthritis, Paraesthesia, Radiculopathy, Rotator cuff syndrome, X-ray abnormal
Clinical narrative: Initial report received on 01 February 2012 from another manufacturer, report # WAES1201USA00639. The initial reporter to this manufacturer had been a health care professional. The following was verbatim from another manufacturer, report #WAES 1201USA00639: "Information has been received from a Registered Pharmacist (P.Ph.) concerning a 68 year old male patient with no pertinent medical history and no drug reactions who on 23 December 2011 was vaccinated intramuscular in left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot#669579/0595AA, exp. 30 August 2012). There was no concomitant medications. On 05 January 2012 the patient call to the pharmacist and said that he could not lift his left arm in which the injection was given. At the time of the report the patient's status was not recovered. Additional information has been received from Registered Pharmacist (R.P.) and Licensed Visiting Nurse (V.L.N.) concerning a 68 year old male patient with diabetes mellitus (type unspecified), hypertension and allergy to codeine and morphine who on 23 December 2011 was vaccinated intramuscular in left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot#669579/595AA, exp. 30 August 2012). Secondary suspect included FLUZONE administered on 23 December 2011, in right arm (dose, route unknown), (Lot#UH477AB). It was reported that patient was in clinic on 13 January 2012, with complaints of right shoulder pain, discomfort in left shoulder, intermittent tingling and cramps of the hands. The Licensed Visiting Nurse (V.L.N.) reported that patient stated his events were due to the PNEUMOVAX 23 and FLUZONE he received in December 2011. On 13 January 2012 the patient underwent an X-ray of the right shoulder which showed arthritis with no bone injury identified and no muscle wasting; diagnosis; osteoarthritis; rotator cuff tendonitis and radiculopathy. The patient was told continue range of motion and to follow-up with physician after MRI was performed (this had not happened as of 26 January 2012). At the time of the report the patient status was unknown. No further information is available." Documents held by sender: None.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: Hyperhidrosis, Joint swelling, Mobility decreased, Oedema peripheral, Pain
Clinical narrative: Sweating, weakness and pains starting in hands, knees and hips. Horrible sharp pain-- I took some Celebrex, but it didn't help. And I took 4 aspirins and went to bed, finally slept couple of hrs. Next morning I would barely move and had to hobble on cane to move around.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: X-ray
Clinical narrative: Sweating, weakness and pains starting in hands, knees and hips. Horrible sharp pain-- I took some Celebrex, but it didn't help. And I took 4 aspirins and went to bed, finally slept couple of hrs. Next morning I would barely move and had to hobble on cane to move around.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: Arthralgia, Arthritis, Asthenia, Guillain-Barre syndrome, Hip fracture
Clinical narrative: Sweating, weakness and pains starting in hands, knees and hips. Horrible sharp pain-- I took some Celebrex, but it didn't help. And I took 4 aspirins and went to bed, finally slept couple of hrs. Next morning I would barely move and had to hobble on cane to move around.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3, TD
Symptoms: Hyperhidrosis, Mobility decreased, Pain in extremity, Walking aid user, X-ray
Clinical narrative: Sweating, weakness and pains starting in hands, knees and hips. Horrible sharp pain-- I took some Celebrex, but it didn't help. And I took 4 aspirins and went to bed, finally slept couple of hrs. Next morning I would barely move and had to hobble on cane to move around.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise, Pain
Clinical narrative: Extreme Fatigue/Malaise (24 hours). Full body aches (24 hours). Chills (5-6 hours).
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Received her TDAP vaccine on 12/16/11. No initial pain at injection site. 12/17/11 am began to have pain in upper left arm. Pain continued to be present. Week after Christmas she was unable to lift arm and pain continued. She saw her PCP 1/31/12 after being advised to by our office. Was treated with NSAIDS. Seen again 2/9/12 and pain is achy to sharp. Still unable to raise left arm over head. Now treated with steroids and physical therapy.
Age: 41.0
Sex: F
Vaccine: YF
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: In the afternoon after receiving yellow fever injection, patient developed redness, swelling, & itching at site in left arm. Reports feeling tired & nauseous last weekend. 1 week later, reports soreness & mild itching. Did not apply ice or heat or take any analgesic.
Age: 41.0
Sex: F
Vaccine: YF
Symptoms: Pain, Pruritus
Clinical narrative: In the afternoon after receiving yellow fever injection, patient developed redness, swelling, & itching at site in left arm. Reports feeling tired & nauseous last weekend. 1 week later, reports soreness & mild itching. Did not apply ice or heat or take any analgesic.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Headache, Impetigo, Infection, Rash papular
Clinical narrative: This medically confirmed spontaneous report (initial receipt 31-Jan-2012) concerns a 67 year old male patient with a medical history of genital herpes. Concomitant therapy included acyclovir, atorvastatin, testosterone gel, paroxetine, combined lisinopril and hydrochlorothiazide. On 30-Nov-2011, the patient received the flu vaccine and ZOSTAVAX. The day after receiving vaccination, on 01-Dec-2011, the patient developed a papular rash on the left groin, the right upper arm and chin, with secondary impetigo on the chin. The reporter stated that 24-48 hours after vaccination, the patient experienced a slight headache and developed 3 'zoster like bumps', not fluid filled. There was one zoster like bump on the arm where the vaccine was not administered, one zoster-like bump was observed in the patient's groin area and one zoster like bump was on the patient's chin. The zoster-like bump on the patient's chin was infected and the patient developed cellulitis on his neck. The patient was treated with cephalexin for a few weeks before resolving. The papular rash and secondary impetigo on the chin resolved on 20-Dec-2011. Patient outcome is not yet recovered.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash vesicular
Clinical narrative: This medically confirmed spontaneous report (initial receipt 31-Jan-2012) concerns a 67 year old male patient with a medical history of genital herpes. Concomitant therapy included acyclovir, atorvastatin, testosterone gel, paroxetine, combined lisinopril and hydrochlorothiazide. On 30-Nov-2011, the patient received the flu vaccine and ZOSTAVAX. The day after receiving vaccination, on 01-Dec-2011, the patient developed a papular rash on the left groin, the right upper arm and chin, with secondary impetigo on the chin. The reporter stated that 24-48 hours after vaccination, the patient experienced a slight headache and developed 3 'zoster like bumps', not fluid filled. There was one zoster like bump on the arm where the vaccine was not administered, one zoster-like bump was observed in the patient's groin area and one zoster like bump was on the patient's chin. The zoster-like bump on the patient's chin was infected and the patient developed cellulitis on his neck. The patient was treated with cephalexin for a few weeks before resolving. The papular rash and secondary impetigo on the chin resolved on 20-Dec-2011. Patient outcome is not yet recovered.
Age: 0.03
Sex: M
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Hep A vaccine given in error instead of Hep B. Provider examined child. No adverse reactions. No signs & symptoms of distress. Hep B was given to opposite site.
Sex: M
Vaccine: FLU3
Symptoms: Respiratory arrest, Respiratory tract infection
Clinical narrative: This spontaneous consumer report (initial received on 01-Feb-2012) concerns a male child with a medical history of immune compromised, with multiple food allergies including corn, turkey, soy, dairy, sesame, eggs, chicken, watermelon, tree nuts, peanuts, onions, garlic, shellfish and fish. In the past (date not provided), the patient had an unspecified reaction to 'DTP' vaccine. The patient received MMR II at 22 months of age and developed a high fever with spots all over the body and vomiting for days. He lost his speech and developed autism. On an unknown date, the patient received the flu vaccine. It was reported the patient stopped breathing and developed a respiratory infection after the flu vaccine (time to onset not reported). The event outcome was not reported. The reporter did not consent to follow up with the physician and did not wish to provide the name of the physician.