chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to 9 patients of unknown age (no patient information provided). On an unknown date, temperature excursion to (Merck) VARIVAX of -7.9 degree centigrade for 79 hours. (Merck) VARIVAX was supported for use within 1 month. On an unknown date, 9 patients were vaccinated with a dose of (Merck) VARIVAX post excursion, lot # J014400, Expiration Date 13-NOV-2015, 0.5 ml, subcutaneously. No adverse effects reported. The patients did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a health professional (manufacturer control number 58348) refers to an elderly female patient of unknown age (over 65 years old). The patient did not have any known allergies. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route not reported, lot # K005797, expiration date 21-MAR-2015, or lot# reported as K07773, expiration date 01-MAY-2015). Concomitant medications were not provided. On 18-AUG-2014 the patient experienced redness, fever in the area upper arm and itching in the area from the last two vials of pneumonia vaccine. After a couple of days it went away on its own and the patient was okay. The healthcare worker stated the office already disposed one of the lost numbers that was used that was causing the issue lot # K005797. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Noticed bump, redness on 10/01/14. Pt c/o itchiness. Today patient improved. Measured in office 4x2.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Hypoaesthesia, Urticaria
Clinical narrative: About 15 minutes after vaccine administered pt complained about a funny taste in her mouth - her face was going numb and her left arm was going numb on the way to the ER - her face broke out in hives.
Age: 4.0
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Rash pustular, Skin lesion
Clinical narrative: Varicella vaccine given on 8-18-14. On 9-20-14, mom noticed small pustule on torso. Very scant pustules noted until 9-25/26 when lesions increased on torso, neck, gluteal folds, and proximal thighs. Patient did not have fever/URI symptoms at any time.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site nodule, Local swelling
Clinical narrative: Patient developed a big knot, size of a baseball at the injection site. The whole arm was swollen and red starting day ! after injection. Patient received antibiotics from his PCP two days after injection. Swelling is subsiding as of day 5.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site rash, Rash, Rash erythematous, Skin lesion
Clinical narrative: Rash after starting antibiotic (ZITHROMAX) and recurring flu vaccine and HPV rash - raised red lesions and surrounding erythema on face and upper extremities and around site of influenza vaccine (R) deltoid.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Injection site rash, Rash
Clinical narrative: Reports dizziness, SOB (within 30 mins of administration) rash at injection site/arm tx: pt took her PROAIR inhaler (2 puffs) and 1 BENADEYL tablet.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Face injury, Fall, Head injury, Pallor
Clinical narrative: Patient received Hepatitis A and meningococcal vaccines around 3:00 pm. Presented to check out window and fainted. Patient fell, hit face and head, alert and oriented, pale and dizzy. Supportive care offered by nurses. EMS called and patient transported to local hospital. Vital signs remained stable. Oxygen provided to patient. Father denies medical problems or allergies.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: Patient received Hepatitis A and meningococcal vaccines around 3:00 pm. Presented to check out window and fainted. Patient fell, hit face and head, alert and oriented, pale and dizzy. Supportive care offered by nurses. EMS called and patient transported to local hospital. Vital signs remained stable. Oxygen provided to patient. Father denies medical problems or allergies.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Crying, Induration, Local swelling, Rash, Skin warm
Clinical narrative: on 09/30/2014 during course of well child immunizations given, adverse reaction happened. Arm - swelling, warmth, rash, arm L at axilla measured 30cm whereas R arm at axilla measured 29, indurated, tender, crying. Child in process of recovering.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: on 09/30/2014 during course of well child immunizations given, adverse reaction happened. Arm - swelling, warmth, rash, arm L at axilla measured 30cm whereas R arm at axilla measured 29, indurated, tender, crying. Child in process of recovering.
Age: 27.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Fever, HA, lightheadedness day following immunization. Returned for eval 0800 10/2/14 with above and worsening pain at site of PPSV 23 immunization. At (R) deltoid, erythema with sharp borders, pain, induration. Rx BACTRUM DS and Pen VK x 7 days, F/U in 4 days.
Age: 27.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, HA, lightheadedness day following immunization. Returned for eval 0800 10/2/14 with above and worsening pain at site of PPSV 23 immunization. At (R) deltoid, erythema with sharp borders, pain, induration. Rx BACTRUM DS and Pen VK x 7 days, F/U in 4 days.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called clinic 10-1-14 about 7:30 pm to c/o swelling, heat to area where Tdap received recently. Patient returned to clinic as directed 10-2-14 to assess swelling sx. (R) DT 12 mm area firm, sl. erythema, warm to touch. States sore if touched. Ice to area today, warm, moist compresses 10-3-14 15-20 min. periods 4-5x/ day. Ibuprofen for pain as directed. To see PCP if not improved by Monday 10-6-14.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Went on 8-30-14 to get the shingle vaccination. The girl never explain about the adverse till after she gave the shot and I would never got the shot. My arm is hurting still today. 10-2-14 I went to the store. 2 x then my doctor. I'm on pain pills can't work.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye pruritus, Neck pain, Swelling
Clinical narrative: 20 m after lightheaded. Then 2 hrs later itchy eyes and swollen. Relieved by BENADRYL. Sore (L) side of neck.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Experienced nausea, weakness and dizziness night of flu shot. No egg allergy. Many flu shots before.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Generalized maculopapular rash on trunk and extremities, non itchy. Patient has no fever no other symptoms. Rash started 3 hours after receiving vaccines.
Age: 37.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Was given Hep B vaccine on her (L) deltoid on 9/30/14 and develop swelling and redness around the vaccination site and warm to touch. Was given antibiotic KEFLEX 500 mg BID x 7 days. Pt w/ several medical problems lymphoma and receiving radiation.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient woke up the day after FLUZONE was administered with a red, swollen and itchy area around the injection site.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Abasia, Arthralgia, C-reactive protein increased, Full blood count, Local swelling
Clinical narrative: 1 wk after vaccine, bilateral knees, ankles and foot pain lasting 1 wk. Pain worsened and she developed swelling of lower legs with rash lasting 1 wk. Unable to walk -> ED.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Metabolic function test, Pain in extremity, Ultrasound Doppler normal, Viral test negative
Clinical narrative: 1 wk after vaccine, bilateral knees, ankles and foot pain lasting 1 wk. Pain worsened and she developed swelling of lower legs with rash lasting 1 wk. Unable to walk -> ED.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot given 9/23/14 at Health Dept. Flu (R) arm and Pneumococcal (PNEUMOVAX 23) (L) arm. 9-25-14 pt. came to H. D. to report (L) arm under and around shot area is warm to touch, red and sl. swollen - noticed today - unsure if there day before. Pt. afebrile.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash.
Age: 31.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site cellulitis, Local swelling, Skin warm
Clinical narrative: Cellulitis at site on injection. Large, swollen red area, hot to touch. Treated with antibiotic.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis to site, red, warm, large circle. Req. Abx tx.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient was given FLUVIRIN instead of FLUZONE HD requested by patient.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Eyelid oedema, Local swelling, Pruritus, Rash
Clinical narrative: Itching, puffy eyes, difficulty breathing, lumpy arm, rash.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Upper extremity mass
Clinical narrative: Itching, puffy eyes, difficulty breathing, lumpy arm, rash.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 24-FEB-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 29-MAY-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may have been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed to 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the temperature stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash on chest/abd/trunk/back/arms started approximately 2 days after immunization. No fever/chills. No pruritus/hives. Given prednisone course by urgent care.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via direct contact, Eye irrigation, Eye irritation, Eye pain, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to a currently 52 years old female patient allergy to BACTRIM and CECLOR with rash and hives. Healthcare worker reported that nurse (who is also the patient) had been inadvertently exposed to ZOSTAVAX (lot number K003596, expiration date 12-MAR-2015) on her eyes (onset date reported as 24/2014) when the nurse was putting the syringe in the container and it ended up splashing in her eye. The patient's eye was "very red", burning and stinging. The outcome of the events was reported as not recovered. Treatment given for the adverse events was a flushing of the eye. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a health professional via a company (manufacturer control number 58348) refers to an elderly male patient of unknown age (over 65 years old). The patient did not have any known allergies. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route not reported, lot # K005797, expiration date 21-MAR-2015, or lot# reported as K007773, expiration date 01-MAY-2015). Concomitant medications were not provided. On 18-AUG-2014 the patient experienced redness, fever in the area upper arm and itching in the area from the last two vials of Pneumonia vaccine. After a couple of days it went away on its own and the patient was okay. The healthcare worker stated the office already disposed one of the lot numbers that was used that was causing the issue lot # K005797. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Discomfort, Erythema, Flushing
Clinical narrative: Flushing and redness occurred within 3-5 minutes of vaccination. Pt was uncomfortable and had back pain for about 5-10 minutes. Flushing and back pain subsided in 20-30 minutes (bad back pain was 5-10 minutes). Called Emergency Squad - BP/BS/PO2 all normal. Gave pt H2O. Pt went home but is going to follow up with her doctor.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 81 year old female patient with glaucoma, no allergies and no pertinent medical history. On 09-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dosage and route unknown) lot # K004148, expiration date: 10-MAY-2014. Concomitant medication included unspecified eye drops for glaucoma. On 09-SEP-2014, the patient had a fever and had soreness at injection site after receiving the PNEUMOVAX 23. The patient stated that she had to leave work on 10-SEP-2014, due to the injection site being red and inflamed and her entire arm was sore and she couldn't move her arm. No treatment was given for the events. The outcome of the events was not recovered. Pharmacist was requesting a lot check on lot# K004148 exp. 10-MAY-2014. This is one of several reports received from same reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 81 year old female patient with glaucoma, no allergies and no pertinent medical history. On 09-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dosage and route unknown) lot # K004148, expiration date: 10-MAY-2014. Concomitant medication included unspecified eye drops for glaucoma. On 09-SEP-2014, the patient had a fever and had soreness at injection site after receiving the PNEUMOVAX 23. The patient stated that she had to leave work on 10-SEP-2014, due to the injection site being red and inflamed and her entire arm was sore and she couldn't move her arm. No treatment was given for the events. The outcome of the events was not recovered. Pharmacist was requesting a lot check on lot# K004148 exp. 10-MAY-2014. This is one of several reports received from same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Diarrhoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pt reported marked upper arm (R) to elbow swelling, redness, pain. Temp 102 degrees, diarrhea, vomiting, nausea and headache. All began same evening shot administered. Lasted several days.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Nausea, Vomiting
Clinical narrative: Pt reported marked upper arm (R) to elbow swelling, redness, pain. Temp 102 degrees, diarrhea, vomiting, nausea and headache. All began same evening shot administered. Lasted several days.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Vomiting
Clinical narrative: Vomiting, hoarseness - 2+ hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Eosinophil count, Eosinophils urine, Headache, Insomnia
Clinical narrative: Left sided headache, insomnia, paresthesia, scattered, sporadic itching, generalized sense of discomfort.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Left sided headache, insomnia, paresthesia, scattered, sporadic itching, generalized sense of discomfort.
Age: 1.29
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Adverse event
Clinical narrative: Adverse effect of medicinal or biological substance not elsewhere classified - Dapt, influenza.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Urticaria
Clinical narrative: Customer received vaccines at 12:15PM on the 17th, felt chills at 7PM, woke up with welts and red deltoid at 6:30AM on the 18th, now Dr. at 1PM, then got refer to ER right after where she was diagnosed with cellulitis and given IV, pain meds, and ABX.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a health professional via company (manufacturer control number 58348) refers to an elderly female patient of unknown age (over 65 years old). The patient did not have any known allergies. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route not reported, lot # K005797, expiration date 21-MAR-2015, or lot# reported as K007773, expiration date 01-MAY-2015). Concomitant medications were not provided. On 18-AUG-2014 the patient experienced redness, fever in the area upper arm and itching in the area from the last two vials of Pneumonia Vaccine. After a couple of days it went away on its own and the patient was okay. The healthcare worker stated the office already disposed one of the lot numbers that was used that was causing the issue lot # K005797. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Flushing, Tachycardia, Tremor
Clinical narrative: Pt is a 26 y/o man who had a reaction consistent of severe flushing/ tachycardia/ chest pain after his PNEUMOVAX, about 1 minute after. EKG showed a sinus tach. His symptoms slowly improved, but we were hesitant to send him out w/o further observation, so EMS was called and transported to MC.
Age: 26.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Electrocardiogram abnormal, Flushing, Sinus tachycardia, Tachycardia
Clinical narrative: Pt is a 26 y/o man who had a reaction consistent of severe flushing/ tachycardia/ chest pain after his PNEUMOVAX, about 1 minute after. EKG showed a sinus tach. His symptoms slowly improved, but we were hesitant to send him out w/o further observation, so EMS was called and transported to MC.
Age: 51.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old male patient. As patient past history, it was reported that patient was not immune-compromised, has not been on any steroids and has no history of immunosuppression. On 20-AUG-2014, the patient was vaccinated with a dose of M-M-R II, Lot # K003822, expiration date on 14-MAR-2016. Co-suspect therapy and concomitant medications were not provided. It was reported that the patient had titers drawn for measles, mumps and rubella on an unspecified date. The titers came back on 12-AUG-2014 stating that the patient had no immunity to rubella, unspecified that the titers were for measles. The patient was administered M-M-R II on 20-AUG-2014. The patient left work on 30-AUG-2014 feeling ill. The patient experienced a rash covering his torso, fever, headache, irritability and night sweats on an unspecified dates. The patient visited his physician on 04-SEP-2014 and on the same date the patient was diagnosed with measles. The patient had returned to work as of 08-SEP-2014, after being told he was not contagious any longer. The patient recovered from event. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Headache, Irritability, Malaise, Measles, Night sweats
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old male patient. As patient past history, it was reported that patient was not immune-compromised, has not been on any steroids and has no history of immunosuppression. On 20-AUG-2014, the patient was vaccinated with a dose of M-M-R II, Lot # K003822, expiration date on 14-MAR-2016. Co-suspect therapy and concomitant medications were not provided. It was reported that the patient had titers drawn for measles, mumps and rubella on an unspecified date. The titers came back on 12-AUG-2014 stating that the patient had no immunity to rubella, unspecified that the titers were for measles. The patient was administered M-M-R II on 20-AUG-2014. The patient left work on 30-AUG-2014 feeling ill. The patient experienced a rash covering his torso, fever, headache, irritability and night sweats on an unspecified dates. The patient visited his physician on 04-SEP-2014 and on the same date the patient was diagnosed with measles. The patient had returned to work as of 08-SEP-2014, after being told he was not contagious any longer. The patient recovered from event. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old male patient. As patient past history, it was reported that patient was not immune-compromised, has not been on any steroids and has no history of immunosuppression. On 20-AUG-2014, the patient was vaccinated with a dose of M-M-R II, Lot # K003822, expiration date on 14-MAR-2016. Co-suspect therapy and concomitant medications were not provided. It was reported that the patient had titers drawn for measles, mumps and rubella on an unspecified date. The titers came back on 12-AUG-2014 stating that the patient had no immunity to rubella, unspecified that the titers were for measles. The patient was administered M-M-R II on 20-AUG-2014. The patient left work on 30-AUG-2014 feeling ill. The patient experienced a rash covering his torso, fever, headache, irritability and night sweats on an unspecified dates. The patient visited his physician on 04-SEP-2014 and on the same date the patient was diagnosed with measles. The patient had returned to work as of 08-SEP-2014, after being told he was not contagious any longer. The patient recovered from event. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Malaise
Clinical narrative: This spontaneous report as received from a 55 year old female patient refers to herself. The patient had no pertinent medical history and no drug reactions nor allergies. On 10-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX 1 injection left side of prophylaxis (lot# not reported). Concomitant therapies included LINZESS 1x and vitamin (unspecified). On 10-SEP-2014, regular lab work was done but no result reported. On 11-SEP-2014, the next day after ZOSTAVAX, the patient experienced a terrible headache that last for a few days. The patient also felt like she was catching a cold and on her left breast "saw some spots than 16-SEP-2014 ("Tuesday") saw many more spots. By 17-SEP-2014 ("Wednesday") the rash had reached from the front other back on her left side." The patient sought medical attentions. The nurse practitioner had seen who diagnosed the shingles (Primary physician was out of town). The patient was treated with valacyclovir 7 day coarse. The outcome of events was unknown. The causality was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Nasopharyngitis, Rash
Clinical narrative: This spontaneous report as received from a 55 year old female patient refers to herself. The patient had no pertinent medical history and no drug reactions nor allergies. On 10-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX 1 injection left side of prophylaxis (lot# not reported). Concomitant therapies included LINZESS 1x and vitamin (unspecified). On 10-SEP-2014, regular lab work was done but no result reported. On 11-SEP-2014, the next day after ZOSTAVAX, the patient experienced a terrible headache that last for a few days. The patient also felt like she was catching a cold and on her left breast "saw some spots than 16-SEP-2014 ("Tuesday") saw many more spots. By 17-SEP-2014 ("Wednesday") the rash had reached from the front other back on her left side." The patient sought medical attentions. The nurse practitioner had seen who diagnosed the shingles (Primary physician was out of town). The patient was treated with valacyclovir 7 day coarse. The outcome of events was unknown. The causality was not reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site swelling, Neuralgia, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 49 year old female patient with sickle cell crisis and no drug reactions/allergies. On an unknown date the patient was admitted to the hospital for a sickle cell crisis. On 01-OCT-2014, at 06:30 (during the stay in the hospital), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were not provided), 0.5 ml, intramuscular in left arm. No concomitant medications were reported. On 01-OCT-2014 the patient developed severe, extensive swelling, redness and pain from the left shoulder to the elbow. No lab diagnostics studies were performed. The patient received BENADRYL and SOLUMEDROL intravenous (IV) as a treatment for adverse events. The outcome of the events was reported as not recovered. The reporter considered the events to be related to PNEUMOVAX 23. The physician stated that the events would prolong the patient's hospitalization. Upon internal review the events were consider to be medically significant. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 49 year old female patient with sickle cell crisis and no drug reactions/allergies. On an unknown date the patient was admitted to the hospital for a sickle cell crisis. On 01-OCT-2014, at 06:30 (during the stay in the hospital), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were not provided), 0.5 ml, intramuscular in left arm. No concomitant medications were reported. On 01-OCT-2014 the patient developed severe, extensive swelling, redness and pain from the left shoulder to the elbow. No lab diagnostics studies were performed. The patient received BENADRYL and SOLUMEDROL intravenous (IV) as a treatment for adverse events. The outcome of the events was reported as not recovered. The reporter considered the events to be related to PNEUMOVAX 23. The physician stated that the events would prolong the patient's hospitalization. Upon internal review the events were consider to be medically significant. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Swelling
Clinical narrative: Injection IM not subcutaneous and patient had swelling with outbreak of shingles on left arm.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle pain and stiffness.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Vertigo, Vision blurred
Clinical narrative: Dizzy, can't focus eyes, vertigo.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Apnoea, Breath holding, Crying, Hyperhidrosis, Hypersomnia
Clinical narrative: Unconsolably crying, sleep terrors, difficulty waking up out of terror/crying spells. Apnea/breath holding requiring more than light stimulation to wake up. Movement monitor alarmed due to hold of breath longer than 20 sec which required me having to pick him up and pat back in order to get him to catch his breath. Fever, sweating and unusually sleeping all day for few days following vaccine.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Sleep terror, Somnolence
Clinical narrative: Unconsolably crying, sleep terrors, difficulty waking up out of terror/crying spells. Apnea/breath holding requiring more than light stimulation to wake up. Movement monitor alarmed due to hold of breath longer than 20 sec which required me having to pick him up and pat back in order to get him to catch his breath. Fever, sweating and unusually sleeping all day for few days following vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood glucose decreased, Hypoglycaemia, Loss of consciousness
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood glucose decreased, Blood potassium decreased, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysgeusia, Fatigue, Headache, Hyperhidrosis, Irritability
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Loss of consciousness, Muscle spasms, Psychomotor hyperactivity
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anger, Blood glucose decreased, Blood potassium decreased, Confusional state, Disorientation
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Dysgeusia, Dysphonia, Hunger, Hyperhidrosis
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Hypoglycaemia, Injection site pain, Irritability, Loss of consciousness, Muscle spasms
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Photopsia, Product quality issue, Visual impairment, Wrong drug administered
Clinical narrative: Pt lost consciousness, was found to be hypoglycemic.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood glucose decreased, Hypoglycaemia, Loss of consciousness
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood glucose decreased, Blood potassium decreased, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysgeusia, Fatigue, Headache, Hyperhidrosis, Irritability
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Loss of consciousness, Muscle spasms, Psychomotor hyperactivity
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anger, Blood glucose decreased, Blood potassium decreased, Confusional state, Disorientation
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Dysgeusia, Dysphonia, Hunger, Hyperhidrosis
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Hypoglycaemia, Injection site pain, Irritability, Loss of consciousness, Muscle spasms
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Photopsia, Product quality issue, Visual impairment, Wrong drug administered
Clinical narrative: Patient reports within 2 minutes of recieving vaccine she had a strong strange taste in her mouth, within 15 minutes started feeling confused, hyper, unfocused with increasing irritability became lightheaded, dizzy and started sweating called school nurse and was taken to nurses office was given Epiephrine and became unconsious and woke up in ambulance at which time blood sugar was tested and was below 30.  At hospital blood sugar tested was 23 started and IV drip with sugar.  Patient reports ER had a hard time stablizing her sugar level and Potassium started decreasing and she expierenced leg cramping.  Patient stated her sugar levels were stablized and she was later released from the ER Blood work said she had recieved Insulin.  She continued with a headache for 24 hours and fatique for 2 days.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Sore throat, and congestion then woke on 10/3/2014 with swollen eyes.
Age: 51.0
Sex: F
Vaccine: TTOX
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Insomnia, Musculoskeletal stiffness
Clinical narrative: After receiving a tetanus shot I experienced intense burning pain radiating from the injection site in the left arm into the shoulder and up into the neck.  Intense pain and stiffness lasted 3-4 days to the point where I was unable to sleep and had extreme difficulty moving without excruciating pain.  Two months later there is still pain and stiffness in the arm near the injection site, shoulder joint and neck.  I have restricted range of motion in the left shoulder.
Age: 51.0
Sex: F
Vaccine: TTOX
Symptoms: Neck pain, Pain
Clinical narrative: After receiving a tetanus shot I experienced intense burning pain radiating from the injection site in the left arm into the shoulder and up into the neck.  Intense pain and stiffness lasted 3-4 days to the point where I was unable to sleep and had extreme difficulty moving without excruciating pain.  Two months later there is still pain and stiffness in the arm near the injection site, shoulder joint and neck.  I have restricted range of motion in the left shoulder.
Age: 89.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal pain upper, Adverse drug reaction, Herpes zoster, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from an 89 year old female patient refers to herself with allergy to dust and grass clippings. The patient's medical history included "heart trouble was irritated when shingles occurred", rheumatic fever as a kid. In October 2009 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported), (0.65 ml, subcutaneous). Concomitant therapies included KEFLEX, FAMVIR and ZOVIRAX and clindamycin. The patient reported that she had experienced shingles, twice a year, for the past 14 years. She reported that since receiving ZOSTAVAX she had gotten shingles twice a year, every year, in the Spring and in the Fall. She described the most recent case of shingles that occurred in approximately August 2014 "a month ago" as "a red and raw rash on the back as big as an apple". She was still experiencing this case of shingles and described that she was "experiencing pain on one shoulder, then the other, and one arm was almost useless. The nerves in her back were almost gone." She went on to say that she believed if she got the shingles again this Spring that she would die. She was currently trying to get ZOSTAVAX again. She reported two physicians that she had seen to try to get ZOSTAVAX. She sought medical attention from a physician at an unspecified time after the latest case of shingles, and he would not give her ZOSTAVAX again or any other treatment. She then sought medical attention from another physician who would not give her ZOSTAVAX either, but prescribed famciclovir in May 2014. She did not specify when the other concomitant medications were prescribed or by whom. No lab diagnostics studies were performed. The patient also reported non-highted AE related to clindamycin used at unspecified time that resulted in urinary tract infection and stomach aches. The outcome of shingles (occurred before August 2014) was unknown. The outcome of other events was reported as not recovered/not resolved. All the events were considered as life threatening and disability by the reporter. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous, Urinary tract infection
Clinical narrative: This spontaneous report as received from an 89 year old female patient refers to herself with allergy to dust and grass clippings. The patient's medical history included "heart trouble was irritated when shingles occurred", rheumatic fever as a kid. In October 2009 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported), (0.65 ml, subcutaneous). Concomitant therapies included KEFLEX, FAMVIR and ZOVIRAX and clindamycin. The patient reported that she had experienced shingles, twice a year, for the past 14 years. She reported that since receiving ZOSTAVAX she had gotten shingles twice a year, every year, in the Spring and in the Fall. She described the most recent case of shingles that occurred in approximately August 2014 "a month ago" as "a red and raw rash on the back as big as an apple". She was still experiencing this case of shingles and described that she was "experiencing pain on one shoulder, then the other, and one arm was almost useless. The nerves in her back were almost gone." She went on to say that she believed if she got the shingles again this Spring that she would die. She was currently trying to get ZOSTAVAX again. She reported two physicians that she had seen to try to get ZOSTAVAX. She sought medical attention from a physician at an unspecified time after the latest case of shingles, and he would not give her ZOSTAVAX again or any other treatment. She then sought medical attention from another physician who would not give her ZOSTAVAX either, but prescribed famciclovir in May 2014. She did not specify when the other concomitant medications were prescribed or by whom. No lab diagnostics studies were performed. The patient also reported non-highted AE related to clindamycin used at unspecified time that resulted in urinary tract infection and stomach aches. The outcome of shingles (occurred before August 2014) was unknown. The outcome of other events was reported as not recovered/not resolved. All the events were considered as life threatening and disability by the reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Cough, Injection site pain, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Severe pain at injection site. Severe pain in arm pit of injected arm. Fever. Post nasal drip. Coughing.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Eye pruritus, Fatigue, Headache
Clinical narrative: Soreness where shot was given, fatigue. By next morning, additional symptoms include itchy eyes, cough, hoarseness, headache. Still experiencing all symptoms 10/03/2014 8:00 AM.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Soreness where shot was given, fatigue. By next morning, additional symptoms include itchy eyes, cough, hoarseness, headache. Still experiencing all symptoms 10/03/2014 8:00 AM.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Fatigue, Hyperhidrosis, Restlessness
Clinical narrative: Woke up sweaty. Ache in back, ankles and wrists. Restless but body exhausted.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Pruritus, Rash, Tenderness, Urticaria
Clinical narrative: Patient reported symptoms started on second day post vaccination with Tdap/Adacel. Symptoms decribed were hives, rash with blisters that itch to the arms, head, fingers, feet, and groing area. These areas are tender to touch per patient. Symptoms are intermittent lasting aproximately 2 hours at a time. Symptoms are ongoing for the past 11 days. No medications taken per patient's wishes.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site pain, Irritability
Clinical narrative: Irritability, large (golf ball) lump at injection site, red and painful. Slight nausea. Aching all over and quite fatigued for 5 days.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: Irritability, large (golf ball) lump at injection site, red and painful. Slight nausea. Aching all over and quite fatigued for 5 days.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Disturbance in attention, Dizziness, Eye swelling, Fatigue
Clinical narrative: Dizziness and mental fogginess within minutes of injection followed by extreme sharp pain in arm. Later fatigue and next day full flu symptoms sore throat congestion low grade fever achy pain cough stuffy the following day sick in bed right eye swollen plus headache congestion and full flu illness extreme fatigue with inability to concentrate.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Influenza, Oropharyngeal pain, Pain
Clinical narrative: Dizziness and mental fogginess within minutes of injection followed by extreme sharp pain in arm. Later fatigue and next day full flu symptoms sore throat congestion low grade fever achy pain cough stuffy the following day sick in bed right eye swollen plus headache congestion and full flu illness extreme fatigue with inability to concentrate.