chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Sensation of heaviness
Clinical narrative: This case was reported by a healthcare professional (nurse, subject) via sales representative and described the occurrence of pain in left arm around injection site in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 October 2013 the subject received a dose of FLUARIX (unknown details, left arm). On 25 October 2013, immediately after vaccination with FLUARIX, the subject experienced pain in left arm around injection site. Per the nurse, "it was immediately painful with a sharp pain that extended all the way down my arm." The nurse also reported that "it was extremely painful that night." Over the next week, the nurse reported that the pain "eased up." The nurse described the pain in left arm around injection site as "left shoulder muscle is 'stiff' and painful" and "worse in the mornings." In 2013, within a month after vaccination with FLUARIX, the subject experienced arm heaviness (post injection site reaction) and injection site reaction (difficulty in moving arm). The nurse described her arm as feeling "heavy and" the nurse has "limited range of motion." The nurse decided to seek medical attention from a doctor. At the time of reporting, the nurse had not yet seen a doctor. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. At the time of reporting, "it has been 3 weeks" and the nurse considered the events as "becoming more of a chronic problem." The healthcare professional considered the events were probably related to vaccination with FLUARIX. The nurse stated that her symptoms were "absolutely 100 percent caused by the flu shot."
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Varicella virus test positive
Clinical narrative: Patient came in to see Dr on 11-18-13. She had a blistering rash on (R) side of body. The swab I did came back (+) for shingles. She had a shingles vaccine in 2011.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, reddening, heat, pain, difficulty moving arm at injection site. Pt stated symptoms started 7 pm same day and symptoms were gone by 11/24/13.
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Erythema, Local swelling, Pain in extremity
Clinical narrative: Swelling-pain-redness-lt arm from elbow to shoulder. Radiate to LT chest.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with sensitivity to bug bites. Her pertinent medical history was reported as none. On 12-NOV-2013, the patient was vaccinated with ZOSTAVAX lot # J010447, dose 0.65 ml, administered via subcutaneous injection. She did not take any concomitant medication. On 13-NOV-2013, the patient experienced the patient developed a big red, itchy and not to painful welt at the injection site. She sought medical attention because of the adverse event at the pharmacy on 14-NOV-2013. The pharmacist reported that the welt got bigger and on 14-NOV-2013 it was 4 to 5 inches in diameter. The pharmacist at the pharmacy advised the patient to take BENADRYL and apply ice to the site. It was not reported if the patient followed the pharmacist's advise. No lab-diagnostic studies were performed. The outcome of big red, itchy and not to painful welt at the injection site was reported as not recovered/not resolved. A causality assessment for the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: 6 days after vaccination - spots on lower right leg further developed a larger area on same leg; Left leg has 1 spot on ankle and lower leg and groin and 2 on inner thigh pt saw MD on 11/15 - Diagnosed with Zoster -given FAMVIR 500mg tid x 7D - No pain - occasional itchiness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mass, Swelling
Clinical narrative: Red, swelling - shoulder down arm approx. 4 inches - lump - still on arm - 3 wks later.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Clonus, Loss of consciousness, Tremor
Clinical narrative: Within 10 minutes of receiving his immunizations he lost consciousness and his hands/arms were shaking with his hands in a "clonic" position. Episode lasted less than 30 sec. - witnessed by RN and LVN.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Bacterial test negative, Blood culture negative, Fungal test negative
Clinical narrative: This report as received from a physician refers to a 40 year old female patient enrolled in a study. The patient's current condition includes anxiety, headache, prochlorperazine maleate allergy, intermittent nausea, jaw pain, penicillin allergy and T-cell lymphoma. The patient's medical history included removed right axillary node. On 03-JAN-2013, the patient was randomized and vaccinated with the first 0.5ml subcutaneous (SC) dose of blinded therapy with V-212 study or placebo. On 08-JAN-2013, the patient had Autologous Hematopoietic Cell Transplants (HCTs). On 04-FEB-2013, the patient was vaccinated with the second 0.5ml subcutaneous (SC) dose of blinded therapy with V-212 study or placebo. On 11-MAR-2013, the patient was vaccinated with the third 0.5ml subcutaneous (SC) dose of blinded therapy with V-212 study or placebo and on 04-APR-2013, was vaccinated with the fourth 0.5ml subcutaneous (SC) dose of blinded therapy with V-212 study or placebo. Other suspect therapies included PNEUMOVAX23 (14-NOV-2013). Concomitant therapies included IMODIUM, FLAGYL, PHENERGAN, LEXAPRO, ATIVAN, ciprofloxacin, FLEXERIL and DILAUDID. On 14-NOV-2013, the patient experienced severe allergic reaction to PNEUMOVAX23 (grade 4) and was hospitalized. The site was waiting for records from hospital for more details. There was no more information reported. On 14-JAN-2013, 16-JAN-2013 and 18-JAN-2013, culture, blood (bacterial and fungal) showed no growth 6 days (normal). On 17-JAN-2013, the patient recovered from severe allergic reaction to PNEUMOVAX23 (grade 4). The reporting investigator felt that severe allergic reaction to PNEUMOVAX23 (grade 4) was not related to study therapy but related to PNEUMOVAX23. During the study, the patient was also placed on ZOFRAN (21-JAN-2013); DOC-Q-LACE (11-MAR-2013) and VICODIN (11-MAR-2013) for jaw pain. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt had swelling at injection site that was very painful, and lasted for about 5 days post vaccination. No treatment was given. Pt has recovered fully.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Irritability, Pyrexia, Urticaria
Clinical narrative: Urticaria, fussiness, fevers to 102.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Urticaria
Clinical narrative: Received Pneumovax Vaccine 11/22/2013 in the afternoon at Personnel Health. In the evening developed hives to left upper arm. Chills and pain to the left arm. Reported to Personnel Health on 11/25/2013. Took diphenhydramine 25 mg.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Crying
Clinical narrative: Excessive, incosolable crying for 5.5 hrs following administration.  Treated at home with Tylenol per mom, but Tylenol did not help. Back to his usual state after 5.5 hrs. Temp max 100.0 rectal.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Hives on and off x 3 days 11/22/13 through 11/25/13. Mom gave Benadryl initially on 11/23/13 and they disappeared only to reoccur daily on 11/24/13 and 11/25/13 both days requiring Benadryl as well.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth, Pyrexia
Clinical narrative: patient mother describes redness, heat and a hard knot at the injection site. Reports fever of 100 degrees F.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Local swelling, Nausea, Pain in extremity
Clinical narrative: Deltoid muscle area swollen, red, hot to touch, and painful. Patient also complained of headache and nausea.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Deltoid muscle area swollen, red, hot to touch, and painful. Patient also complained of headache and nausea.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Muscular weakness
Clinical narrative: Sudden onset of chills, muscle weakness, rigors.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Local swelling, Nodule
Clinical narrative: Localized erythmea 3" x 3 1x2", raised, hot, with white nodule at center
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Pt reported to mother to having a raised 6cm rash that was hot to touch at injection site. It remained unchanged on 11/10/2013. Pt was offered Benadryl by her mother, but she declined. Rash was noted to have improved by 11/11/2013. Sh called the office on 11/11/2013 to report this and was advised to monitor and call office if rash did not continue to improve.
Age: 17.0
Sex: F
Vaccine: FLUN4, HEPA, MNQ, TD, VARCEL
Symptoms: Migraine, Nausea, Vision blurred
Clinical narrative: Patient woke up next morning on 11/27/2013 after receiving vaccines complaining of a migraine. Migraine per mother led to blurry vision and nausea.
Age: 1.06
Sex: F
Vaccine: FLUX, MMR
Symptoms: Diarrhoea, Nasopharyngitis, Pain, Pyrexia, Rash
Clinical narrative: Runny nose, fevers, body aches, red spots in mouth, covered head to toe in rash, rash around the eye, diarrhea. Saw Dr. at 3pm Monday November 25th. Said it was reaction to shot and that she had a cold and a throat virus. Treatment: alternating ibuprofen and Tylenol for pain and fever. Rash has gotten worse since Monday. Doctor prescribed us antibiotics for her runny nose.
Age: 1.06
Sex: F
Vaccine: FLUX, MMR
Symptoms: Rash erythematous, Rash generalised, Rhinorrhoea, Vaccination complication, Viral pharyngitis
Clinical narrative: Runny nose, fevers, body aches, red spots in mouth, covered head to toe in rash, rash around the eye, diarrhea. Saw Dr. at 3pm Monday November 25th. Said it was reaction to shot and that she had a cold and a throat virus. Treatment: alternating ibuprofen and Tylenol for pain and fever. Rash has gotten worse since Monday. Doctor prescribed us antibiotics for her runny nose.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Herpes zoster, Hyperaesthesia, Injection site pain, Rash
Clinical narrative: Received flu shot on Thursday 11/21/13.  Shortly afterward felt soreness in arm where shot was given and then in lower back.  Skin felt unusually sensitive over the weekend and back was unusually sore.  On Monday 11/25/13, a rash appeared on my abdomen and lower back.  Went to the doctor and was diagnosed with shingles.  Never had shingles before.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: On 11/24/13, patient states that he has been to physician twice with complaints of arm pain. Physician states that pain was caused by receiving his flu shot too high in his arm.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Echocardiogram, Electrocardiogram, Full blood count, Supraventricular tachycardia
Clinical narrative: vomiting, diarrhea, shaking, paroxysmal supraventricular tachycardia (240 bpm).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: vomiting, diarrhea, shaking, paroxysmal supraventricular tachycardia (240 bpm).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: On 11/26/13, patient states that is still having pain in her arm after receiving flu shot. She shows that she received her flu shot in the middle of her upper arm (bicep/tricep area).
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient felt like fainting right after administration of vaccine. Just advised patient remain seated.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Asthenia, C-reactive protein increased, Laboratory test normal, Myalgia, Nausea
Clinical narrative: Nausea and vomiting followed by widespread muscle aches, severe and debilitating, has gone on for weeks requiring prednisone for symptom control.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Red blood cell sedimentation rate increased, Vomiting, White blood cell count increased
Clinical narrative: Nausea and vomiting followed by widespread muscle aches, severe and debilitating, has gone on for weeks requiring prednisone for symptom control.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Atrial fibrillation, Blood test normal, Borrelia test negative, Myalgia, Pain
Clinical narrative: Nausea and vomiting followed by widespread muscle aches, severe and debilitating, has gone on for weeks requiring prednisone for symptom control.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Vomiting
Clinical narrative: Nausea and vomiting followed by widespread muscle aches, severe and debilitating, has gone on for weeks requiring prednisone for symptom control.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Asthenia, C-reactive protein increased, Laboratory test normal, Myalgia, Nausea
Clinical narrative: Vomiting and severe muscle pain. Pain increased daily especially through the night. Prednisone 40 mg per day was finally prescribed after 5 weeks of trying to figure out what was happening. Now I am on Prednisone and starting to taper off of it 5 mg. per week in hope of the pain disipating. I have also started having Atrial Fibrillation (2 episodes) to date.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Red blood cell sedimentation rate increased, Vomiting, White blood cell count increased
Clinical narrative: Vomiting and severe muscle pain. Pain increased daily especially through the night. Prednisone 40 mg per day was finally prescribed after 5 weeks of trying to figure out what was happening. Now I am on Prednisone and starting to taper off of it 5 mg. per week in hope of the pain disipating. I have also started having Atrial Fibrillation (2 episodes) to date.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Atrial fibrillation, Blood test normal, Borrelia test negative, Myalgia, Pain
Clinical narrative: Vomiting and severe muscle pain. Pain increased daily especially through the night. Prednisone 40 mg per day was finally prescribed after 5 weeks of trying to figure out what was happening. Now I am on Prednisone and starting to taper off of it 5 mg. per week in hope of the pain disipating. I have also started having Atrial Fibrillation (2 episodes) to date.
Age: 55.0
Sex: M
Vaccine: FLU3, TDAP, FLUX, TD
Symptoms: Vomiting
Clinical narrative: Vomiting and severe muscle pain. Pain increased daily especially through the night. Prednisone 40 mg per day was finally prescribed after 5 weeks of trying to figure out what was happening. Now I am on Prednisone and starting to taper off of it 5 mg. per week in hope of the pain disipating. I have also started having Atrial Fibrillation (2 episodes) to date.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Rash
Clinical narrative: Localized redness to right deltoid, not raised, size: 70mm x 80mm. No fever.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: Diffuse head and facial swelling and urticaria. Admit to hosp for 3 days given epinephrine, Solumedrol and Benadryl
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 1 month of pain close to injection site, with reduced ROM, tenderness to palpation.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Pt desrcibes a large raised/sore bump that developed into a black/blue mark around the injection site. Pt describes developing hives all over on 11/27.
Age: 2.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Urticaria
Clinical narrative: Hives over both legs and extending up the torso to the lower chest.
Age: 2.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Urticaria
Clinical narrative: 9 hours after flu shot got hives.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Crying, Decreased eye contact, Dysarthria
Clinical narrative: Fever up to 102, Sleeping most of the day, after a few days of this, crying all the time, could not lye baby flat had to sleep sitting up. Congestion, vomiting over the course of next week, then odd behaviors, repetetive banging of objects, would not look at us, crawling into small spaces, appeared to have had a stroke, dragging back leg, slurring speech of the few words the baby had, then lost speech within the month.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Gait disturbance, Hypersomnia, Mobility decreased, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever up to 102, Sleeping most of the day, after a few days of this, crying all the time, could not lye baby flat had to sleep sitting up. Congestion, vomiting over the course of next week, then odd behaviors, repetetive banging of objects, would not look at us, crawling into small spaces, appeared to have had a stroke, dragging back leg, slurring speech of the few words the baby had, then lost speech within the month.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Sleep disorder, Vomiting
Clinical narrative: Fever up to 102, Sleeping most of the day, after a few days of this, crying all the time, could not lye baby flat had to sleep sitting up. Congestion, vomiting over the course of next week, then odd behaviors, repetetive banging of objects, would not look at us, crawling into small spaces, appeared to have had a stroke, dragging back leg, slurring speech of the few words the baby had, then lost speech within the month.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Aphagia, Arthralgia, Fatigue, Infertility female
Clinical narrative: red bumps covered joints, then hands became severely swollen, couldn't open doors, tie shoes, write my name. after that my joints became sore and swollen and my mouth was covered in sores to the point where I could not eat. I was later diagnosed with rheumatoid arthritis and possibly lupus. I also suffered from chronic fatigue. in 2011 my husband and I started trying for our second child. we later found out I had unexplained secondary infertility and are still struggling and spending countless dollars trying to conceive. this past year I was diagnosed with trigeminal neuralgia. I was being treated for the rheumatism with several medications and injections however those meds are on hold while trying to conceive. I have also had to take several infertility medications, none of which have worked.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Laboratory test, Local swelling, Rash erythematous, Rheumatoid arthritis
Clinical narrative: red bumps covered joints, then hands became severely swollen, couldn't open doors, tie shoes, write my name. after that my joints became sore and swollen and my mouth was covered in sores to the point where I could not eat. I was later diagnosed with rheumatoid arthritis and possibly lupus. I also suffered from chronic fatigue. in 2011 my husband and I started trying for our second child. we later found out I had unexplained secondary infertility and are still struggling and spending countless dollars trying to conceive. this past year I was diagnosed with trigeminal neuralgia. I was being treated for the rheumatism with several medications and injections however those meds are on hold while trying to conceive. I have also had to take several infertility medications, none of which have worked.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Stomatitis, Trigeminal neuralgia
Clinical narrative: red bumps covered joints, then hands became severely swollen, couldn't open doors, tie shoes, write my name. after that my joints became sore and swollen and my mouth was covered in sores to the point where I could not eat. I was later diagnosed with rheumatoid arthritis and possibly lupus. I also suffered from chronic fatigue. in 2011 my husband and I started trying for our second child. we later found out I had unexplained secondary infertility and are still struggling and spending countless dollars trying to conceive. this past year I was diagnosed with trigeminal neuralgia. I was being treated for the rheumatism with several medications and injections however those meds are on hold while trying to conceive. I have also had to take several infertility medications, none of which have worked.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dyskinesia, Eyelid function disorder
Clinical narrative: Patient began to have changes in smile and when she closed right eye. Right eye would not close completely and right side of mouth would not move. She was treated with prednisolone 1 mg - 5 day treatment.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blood pressure increased, Computerised tomogram head, Dehydration, Diplopia, Haemorrhage intracranial
Clinical narrative: Double vision, hearing changes ("tinty sound - helium like speech), decreased hearing ability, increased sense of smell, photosensitivity, severe headache, elevated blood pressure (systolic) (180-200/90). Hospitalized - 11/15/13. Treated for dehydration. Pain down spine. Released from hospital 11/18/13.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Hearing impaired, Hypoacusis, Nuclear magnetic resonance imaging brain abnormal, Parosmia
Clinical narrative: Double vision, hearing changes ("tinty sound - helium like speech), decreased hearing ability, increased sense of smell, photosensitivity, severe headache, elevated blood pressure (systolic) (180-200/90). Hospitalized - 11/15/13. Treated for dehydration. Pain down spine. Released from hospital 11/18/13.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Photosensitivity reaction, Spinal pain
Clinical narrative: Double vision, hearing changes ("tinty sound - helium like speech), decreased hearing ability, increased sense of smell, photosensitivity, severe headache, elevated blood pressure (systolic) (180-200/90). Hospitalized - 11/15/13. Treated for dehydration. Pain down spine. Released from hospital 11/18/13.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Got very bad rxn pneumonia shot. 11-25-13 around 7 PM inj site became itchy and swelled up like a balloon and rash developed underneath her arm. She visited her Dr. next day and Dr. said he never saw a reaction like this before and Dr. gave her Rx's for BENADRYL and erythromycin.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Skin warm
Clinical narrative: She had fatigue and warm red area that was spreading down arm. Treated wtih doxycycline and Nystating/triamcin cream.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen (L) upper arm.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Accidentally gave Hepatitis A vaccine when I meant to give Hib.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 13-NOV-2013, the patient was vaccinated with PEDVAXHIB (lot number 1310AA expiration date 16-AUG-2013), 0.5 ml, intramuscular. No adverse effect reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV, TD
Symptoms: Computerised tomogram normal, Discomfort, Malaise, Musculoskeletal chest pain, Painful respiration
Clinical narrative: This spontaneous report as received from a consumer refers to her 54 year old husband. In October 2013, the patient was vaccinated with a dose of PNEUMOVAX23 lot # J007060, expiration date 28-AUG-2014 (dose, frequency and route were not provided). Other suspect therapies included Td, absorbed (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not provided). The wife of the patient reported that her husband was at death's door with illness that occurred after receiving PNEUMOVAX23. The reporter stated that, at an unspecified time after receiving PNEUMOVAX23 and Td, absorbed (manufacturer unknown), the patient began to feel ill, spiking a fever, finding it "painful to breath" and experiencing extreme rib pain and discomfort. As the patient's discomfort increased, he visited the emergency room of a hospital, "due to the seriousness of his condition." Computerized axial tomography (CAT) scan "ruled out" cancer and a blood clot. On 16-NOV-2013, the patient was diagnosed with pneumonia and a collapsed lung and was admitted, according to his wife, who mentioned being "told" that her husband had a "dent" X-ray. The patient remained hospitalized at the time of the report, where he was being treated with both oral and intravenous antibiotics. The outcome of pneumonia and collapsed lung was reported as not recovered/not resolved. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV, TD
Symptoms: Pneumonia, Pneumothorax, Pyrexia, X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to her 54 year old husband. In October 2013, the patient was vaccinated with a dose of PNEUMOVAX23 lot # J007060, expiration date 28-AUG-2014 (dose, frequency and route were not provided). Other suspect therapies included Td, absorbed (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not provided). The wife of the patient reported that her husband was at death's door with illness that occurred after receiving PNEUMOVAX23. The reporter stated that, at an unspecified time after receiving PNEUMOVAX23 and Td, absorbed (manufacturer unknown), the patient began to feel ill, spiking a fever, finding it "painful to breath" and experiencing extreme rib pain and discomfort. As the patient's discomfort increased, he visited the emergency room of a hospital, "due to the seriousness of his condition." Computerized axial tomography (CAT) scan "ruled out" cancer and a blood clot. On 16-NOV-2013, the patient was diagnosed with pneumonia and a collapsed lung and was admitted, according to his wife, who mentioned being "told" that her husband had a "dent" X-ray. The patient remained hospitalized at the time of the report, where he was being treated with both oral and intravenous antibiotics. The outcome of pneumonia and collapsed lung was reported as not recovered/not resolved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Came into office on 11-22-13 and described redness and swelling at site of vaccine on left arm. Patient to continue with AUGMENTIN and to keep the area clean. Patient also came into office on 11-21-13 and described area as itching and painful to lift arm. AUGMENTIN given.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Rash
Clinical narrative: Patient had headache, rash on neck and back. Was told to give BENADRYL and TYLENOL per MD. Rash went away after giving BENADRYL per mom.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist (who also heard of the case through another unspecified pharmacist within her workplace) via a company representative refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 injection route (lot and dose not reported). At the same arm was administered concomitant influenza virus vaccine (manufacturer unknown) (lot, dose, route and indication not reported). Concomitant medication was not reported. On an unknown date, the patient experienced pronounced injection site reaction with redness, soreness and swelling. Therapy with PNEUMOVAX23 was discontinued and not reintroduced. Action taken regarding therapy with influenza virus vaccine (manufacturer unknown) was not reported. The outcome of pronounced injection site reaction with redness, soreness and swelling was not reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a registered pharmacist via a field employee refers to a male patient of unknown age. On an unknown date, reported as "years ago", the patient was vaccinated with ZOSTAVAX VIAL DRY SD 19.4 MUNIT (dose, duration and lot number were not reported). No concomitant medications were reported. On an unknown date, reported as "recently", the patient developed shingles. As of 18-NOV-2013, the patient had a rash on his stomach and was experiencing postherpetic neuralgia. The patient sought medical attention, went to pharmacist. The outcome of rash on his stomach, postherpetic neuralgia and shingles was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Within 15 minutes of receiving flu vaccine pt's. (L) upper arm became swollen, red, blotchy and warm to the touch. Doctor gave pt. 25mg BENADRYL and 60 mg oral prednisone and area was iced. Pt. was observed 30-45 minutes - swelling/redness decreased.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to an over 80 years old male patient. In July 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, frequency and route not reported). Approximately on 06-NOV-2013 (reported as a week ago), the patient made a phone call to the physician and reported having blister on his head that were painful. The physician had not yet seen the patient and had made no diagnosis. No treatment was given for adverse event. No lab diagnostics studies performed. The patient still had the blisters on his head but he was no longer in pain. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, dose, frequency and route unspecified). On an unknown date the patient experienced injection site irritation after receiving the vaccine. No lab diagnostics study was performed. The outcome of the event was reported as recovering/resolving. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old patient. On 08-NOV-2013 the patient was vaccinated with an adult dose of RECOMBIVAX HB (lot #, expiration date, dose, route, indication not reported) instead of a pediatric dose of RECOMBIVAX HB. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with no drug allergies/reactions. On 08-NOV-2013 the patient was vaccinated with a dose of  ZOSTAVAX (lot # J006831, expiration date 14-SEP-2013, 0.65 ml, subcutaneously. On an unknown date in November 2013 the injection site became painful to touch and painful with flexing of the arm after the patient was administered ZOSTAVAX. The patient called the pharmacist on 11-NOV-2013 and stated that these adverse symptoms had not improved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Middle insomnia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. Patient with no drug reactions or allergies. On 12-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J002693, expiration date 07-JUN2014) route not reported for vaccination. There was no concomitant medication reported. On 13-NOV-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as pain (the pain was described as 7 or 8 on scale of 10, that caused loss of sleep) and itching (no rash) at the injection site of the ZOSTAVAX vaccination. On an unspecified date in November 2013 the patient sought for medical attention and contacted pharmacist. No treatment was given for the adverse events. No lab diagnostic studies were performed. The outcomes of the events were reported as not recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Insomnia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. Patient with no drug reactions or allergies. On 12-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J002693, expiration date 07-JUN2014) route not reported for vaccination. There was no concomitant medication reported. On 13-NOV-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as pain (the pain was described as 7 or 8 on scale of 10, that caused loss of sleep) and itching (no rash) at the injection site of the ZOSTAVAX vaccination. On an unspecified date in November 2013 the patient sought for medical attention and contacted pharmacist. No treatment was given for the adverse events. No lab diagnostic studies were performed. The outcomes of the events were reported as not recovered. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Upper arm pain when pulling clothes off overhead, difficulty rolling over in bed when using arm for leverage, treated with naproxen.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Cold sweat, Discomfort
Clinical narrative: Started low grade fever, aches, pains, joint pain, chills, cold sweats.  This lasted 1 - 2 days.  Low grade fever continued for 5 days.  General malaise continued 2 days longer.  On the 8 day, I developed a itchy rash that has lasted intermittently 5 days now, muscle aches, joint pain returned (with a vengence) along with generalized swelling, especially in the hands and feet, and fever.  So much discomfort that I am unable to perform ADLs with efficiency.  On day 11 I went to my family doctor who gave me a shot of Toradol for the swelling and discomfort, advised me to take OTC ibuprofen, and prescribed and antibiotic (Keflex TID), even though he believes this is a viral sickness.  This brings us to a total of 13 days of reaction / sickness at this point in time.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: Started low grade fever, aches, pains, joint pain, chills, cold sweats.  This lasted 1 - 2 days.  Low grade fever continued for 5 days.  General malaise continued 2 days longer.  On the 8 day, I developed a itchy rash that has lasted intermittently 5 days now, muscle aches, joint pain returned (with a vengence) along with generalized swelling, especially in the hands and feet, and fever.  So much discomfort that I am unable to perform ADLs with efficiency.  On day 11 I went to my family doctor who gave me a shot of Toradol for the swelling and discomfort, advised me to take OTC ibuprofen, and prescribed and antibiotic (Keflex TID), even though he believes this is a viral sickness.  This brings us to a total of 13 days of reaction / sickness at this point in time.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic, Viral infection
Clinical narrative: Started low grade fever, aches, pains, joint pain, chills, cold sweats.  This lasted 1 - 2 days.  Low grade fever continued for 5 days.  General malaise continued 2 days longer.  On the 8 day, I developed a itchy rash that has lasted intermittently 5 days now, muscle aches, joint pain returned (with a vengence) along with generalized swelling, especially in the hands and feet, and fever.  So much discomfort that I am unable to perform ADLs with efficiency.  On day 11 I went to my family doctor who gave me a shot of Toradol for the swelling and discomfort, advised me to take OTC ibuprofen, and prescribed and antibiotic (Keflex TID), even though he believes this is a viral sickness.  This brings us to a total of 13 days of reaction / sickness at this point in time.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hepatitis B antibody negative, Hypoaesthesia, Migraine, Multiple sclerosis
Clinical narrative: This was the first time I received the HEP B vaccine as an adult. I had received this vaccine series a total of 3 times as an adults, and was told each time vaccine didn't take but was safe to have again. After each time I had this vaccine all symptoms I had after first vaccine increased and new symptoms emerged leading to a diagnosis of Multiple Sclerosis (MS) a about 2years that was so progressed that I needed immediate infusion to try and reverse effects. Symptoms I started having after first vaccine: Migraines with dizziness with right facial hand and arm numbness that accompanied the migraine. These symptoms got worse after I received my second series in 2004 at clinic. I had a MRI of head that showed spots, they thought I might have MS. I was started a MS medication and the was told later that I didn't I had my 3rd Hep B series maybe 3 years about which increased symptoms to syncope, vertigo severe migraines and the my confirmed Dx of MS
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Syncope, Vertigo
Clinical narrative: This was the first time I received the HEP B vaccine as an adult. I had received this vaccine series a total of 3 times as an adults, and was told each time vaccine didn't take but was safe to have again. After each time I had this vaccine all symptoms I had after first vaccine increased and new symptoms emerged leading to a diagnosis of Multiple Sclerosis (MS) a about 2years that was so progressed that I needed immediate infusion to try and reverse effects. Symptoms I started having after first vaccine: Migraines with dizziness with right facial hand and arm numbness that accompanied the migraine. These symptoms got worse after I received my second series in 2004 at clinic. I had a MRI of head that showed spots, they thought I might have MS. I was started a MS medication and the was told later that I didn't I had my 3rd Hep B series maybe 3 years about which increased symptoms to syncope, vertigo severe migraines and the my confirmed Dx of MS
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Both legs falling asleep, weak and tingling. Finger tips tingling.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Joint swelling, Swelling face
Clinical narrative: Swollen left cheek (face) and swollen right hand knuckles.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema, Pain in extremity
Clinical narrative: Intense pain (7/10) that radiates down my arm, erythema, and edema at injection site and surrounding tissue on to chest and down into axillary space. Tx - Ibuprofen & cold compress.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown demographics. On unknown dates in 2013, unknown number of patients were vaccinated with VARIVAX (Merck). Medical assistant reported that VARIVAX (Merck) were stored as high as 8 degree Fahrenheit everyday through September, October and November 2013. The vaccine that was improperly stored in September, October and the beginning of November have been used to vaccinate patients. No adverse effect was reported. Lot number and expiry dates were not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a 65 year old female speech pathologist with allergy to penicillin referring on herself. Patient had no pertinent medical history. On 11-NOV-2013, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (dose, route and lot number were not reported). Concomitant therapies included VAGIFEM and EVISTA. On 12-NOV-2013, the patient developed a red, raised area at the injection site following the administration of ZOSTAVAX. No treatment was given for the adverse event, no laboratory diagnostics studies were performed. The outcome of red, raised area at the injection site was reported as recovering. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 66 year old patient (second of 2 patients). On 20-NOV-2013 the patient was vaccinated with ZOSTAVAX vial of lot # J001729 and expiry date 20-OCT-2013, dose 0.65 ml, via subcutaneous route. The patient  had received an expired dose of ZOSTAVAX. No adverse effect was reported. This is 2 of 2 reports received from same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. There was no pertinent medical history. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX via of lot # J006156, expiry date 30-AUG-2014, single dose, 0.65 milliliters, via subcutaneous route. Concomitant medications were none. The pharmacist reported that the patient developed redness, swelling, and itching at the ZOSTAVAX injection site. The swelling was about 2.5 by 1.25 inches. The outcome of events was reported as not recovered/not resolved. No treatment was given for events and pharmacist was called by patient to seek medical attention. No lab diagnostic test was performed. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. There was no pertinent medical history. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX via of lot # J006156, expiry date 30-AUG-2014, single dose, 0.65 milliliters, via subcutaneous route. Concomitant medications were none. The pharmacist reported that the patient developed redness, swelling, and itching at the ZOSTAVAX injection site. The swelling was about 2.5 by 1.25 inches. The outcome of events was reported as not recovered/not resolved. No treatment was given for events and pharmacist was called by patient to seek medical attention. No lab diagnostic test was performed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report refers to a female patient of unknown age. The patient had drug reaction/allergy with butalbital (manufacturer unknown). The patient had shingles for six years, approximately since 2007. On an unknown date the patient was vaccinated with ZOSTAVAX single dose, subcutaneous. Dose, lot and expiry date were unknown. The patient reported that she received the ZOSTAVAX vaccine as treatment for an existing case of shingles. The patient reported that she still remained in extreme pain even after vaccination. The outcome of extreme pain was reported as not resolved. Additional information has been requested.
Age: 1.7
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 month old patient. On 19-NOV-2013 the patient was vaccinated with VARIVAX (Merck) (dose and route not reported) and PROQUAD (dose and route not reported) on the same day. No adverse effects were reported. It was unknown if the patient sought medical attention or not. At the time of report, the status of patient was unknown. Additional information has been requested.
Age: 2.5
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 2 years and 5 months old female patient. On 19-NOV-2013 the patient was vaccinated with the first dose of M-M-R II (lot # 1579AA, expiry date 12-OCT-2013, 0.5 ml, intramuscular) and it was expired. No adverse effects reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with penicillin allergy. On 08-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J006155, expiration date: 30-AUG-2014, one injection in the left arm. On 09-NOV-2013 the patient began to develop redness, swelling, warmth, and blistering 1 inch by 3 inches, at the injection site. She took an unknown non-drowsy antihistamine and ibuprofen during the day and BENADRYL during the night. On the morning of 10-NOV-2013 the red, warm, reaction area around the blister had increased in size to 5 inches by 6 inches, the entire back of her arm, and is hot to touch. The area has a blistery cellulitis appearance. It is unknown if there is any relevant laboratory data. As of 10-NOV-2013 it is unknown if she will receive another injection of ZOSTAVAX. At the time of this report the patient did not recover from the events of blisters, redness, warmth and a blistering cellulitis appearance around the injection site. The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 26 year old female patient. Pertinent medical history and drug reactions/allergies were none. On 06-NOV-2013 the patient was vaccinated with GARDASIL dose 3 (dose, route, lot and expiry date unknown). The patient became pregnant with LMP of 30-JUL-2013 and EDD of 06-MAY-2014. At the time of report, patient was in 14 weeks gestation. The pregnancy outcome was outcome pending. The patient had received third dose of GARDASIL while she was pregnant. No adverse effects were reported. Lab diagnostics studies performed were routine prenatal laboratory studies. The patient went to see nurse practitioner to seek medical attention. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a twenty eight year old patient who was vaccinated with dose 1 of GARDASIL on 24-NOV-2013. Dose, route, lot and expiry date were unknown. No adverse effects were reported. Additional information has been requested.