chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Gingival pain, Malaise, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Since onset, the problem has been gradually worsening. Affected locations: Entire body, started on face neck and chest, has spread to entire body. Associated symptoms include sore throat, malaise, fatigue, non-blanching rash, fever, and myalgias. Negative for cough, congestion, shortness of breath, vomiting, nail changes, joint pain, facial edema, painful lesions, rhinorrhea, headache, and diarrhea. Symptoms are relieved by OTC analgesics/fever reducers. Associated symptoms include chills, arthalgia (2 days ago for a few days), and fever (tactile, felt chilled). Negative for ear pain (Reports she got dizzy for a few minutes on Friday (2 days ago) right top gums hurts, reports bleeding when she brushes her teeth. Right side of throat started hurting this morning). Risk factors include Negative for sick contacts. PMH significant for Negative for tuberculosis, cancer, immunocompromised, renal insufficiency, liver disease, and HIV.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Since onset, the problem has been gradually worsening. Affected locations: Entire body, started on face neck and chest, has spread to entire body. Associated symptoms include sore throat, malaise, fatigue, non-blanching rash, fever, and myalgias. Negative for cough, congestion, shortness of breath, vomiting, nail changes, joint pain, facial edema, painful lesions, rhinorrhea, headache, and diarrhea. Symptoms are relieved by OTC analgesics/fever reducers. Associated symptoms include chills, arthalgia (2 days ago for a few days), and fever (tactile, felt chilled). Negative for ear pain (Reports she got dizzy for a few minutes on Friday (2 days ago) right top gums hurts, reports bleeding when she brushes her teeth. Right side of throat started hurting this morning). Risk factors include Negative for sick contacts. PMH significant for Negative for tuberculosis, cancer, immunocompromised, renal insufficiency, liver disease, and HIV.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Bursa disorder, Insomnia, Joint injury, Musculoskeletal discomfort
Clinical narrative: PT had persisting shoulder pain/weakness/discomfort, difficulty sleeping due to pain. She did not respond to pain meds/rest/stretching/time. She tried nsaids/pain meds/steriods and was evaluated by a PMR doctor and orthopedic shoulder specialist and underwent MRI. This showed a full thickness tear in the left  suprspinatus tendon and partial infraspinatus injury and bursal edema. This was felt by me and patient to be consistent with SIRVA injury "shoulder pain after vaccine administration" . The patient underwent surgery to repair this injury early August 2016.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Oedema, Pain, Rotator cuff syndrome
Clinical narrative: PT had persisting shoulder pain/weakness/discomfort, difficulty sleeping due to pain. She did not respond to pain meds/rest/stretching/time. She tried nsaids/pain meds/steriods and was evaluated by a PMR doctor and orthopedic shoulder specialist and underwent MRI. This showed a full thickness tear in the left  suprspinatus tendon and partial infraspinatus injury and bursal edema. This was felt by me and patient to be consistent with SIRVA injury "shoulder pain after vaccine administration" . The patient underwent surgery to repair this injury early August 2016.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Shoulder operation
Clinical narrative: PT had persisting shoulder pain/weakness/discomfort, difficulty sleeping due to pain. She did not respond to pain meds/rest/stretching/time. She tried nsaids/pain meds/steriods and was evaluated by a PMR doctor and orthopedic shoulder specialist and underwent MRI. This showed a full thickness tear in the left  suprspinatus tendon and partial infraspinatus injury and bursal edema. This was felt by me and patient to be consistent with SIRVA injury "shoulder pain after vaccine administration" . The patient underwent surgery to repair this injury early August 2016.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Patient became dizzy, nauseated and developed blurred vision.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Amnesia, Computerised tomogram head, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: Friday, blacked out at play practice, couldn't remember anything before or after. Saturday did same thing 3 more times. Took him to the ER on Sunday diagnosed him with seizures.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging, Scan with contrast, Seizure
Clinical narrative: Friday, blacked out at play practice, couldn't remember anything before or after. Saturday did same thing 3 more times. Took him to the ER on Sunday diagnosed him with seizures.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site rash, Pyrexia, Tremor
Clinical narrative: Onset of low grade fever, chills, body shakes, severe pain at injection site requiring ice pack, rash around injection site.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with an unspecified number of improperly stored ROTATEQ (dosing details were not reported) lot # L042216, expiry: 13-JUN-2017 lot#L035510, expiry: 13-MAY-2017 and lot#L029615, expiry:15-MAY-2017. There were no product quality complaints (PQC) involved. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOIVAX 23 which had lot # M000386, expiry date: 17-AUG-2017 (route, dose and anatomical place of vaccination were not provided). The vaccines were exposed to temperature of 74 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX which had the lot # L037791, expiry date: 30-DEC-2016 (route, dose and anatomical place of vaccination were not provided). The vaccines were exposed to temperature of 41 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # L025738, expiry date: 14-AUG-2017, lot # L029631, expiry date: 14-AUG-2017 and lot # L044694, expiry date 04-FEB-2018 (route, dose and anatomical place of vaccination were not provided). The vaccines were exposed to temperature of 74 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a consumer refers to his 11 year old daughter. The patient's pertinent medical history and concurrent conditions were not provided. On 10-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. Since the evening of 10-AUG-2016, the patient had been experiencing severe musculoskeletal pain in both her shoulders. No treatment was given to the patient. The patient did not seek medical attention. At the time of the report, the patient had not recovered. The consumer did not assess the relationship of the event to GARDASIL 9. No product quality complaint was involved on this case. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA which had lot # L043209, expiry date: 17-SEP-2017 and lot # M003011, expiry date: 15-NOV-2017 (route, dose and anatomical place of vaccination were not provided). The vaccines were exposed to temperature of 74 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (dosing details were not reported) lot # M011116, expiry date:17-JUN-2016. There were no product quality complaints (PQC) involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (reported as RECOMBIVAX) (dosing details were not reported) lot# L044694, expiry:04-FEB-2018. There were no product quality complaints (PQC) involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot#L039640, expiry:24-AUG-2017. There were no product quality complaints (PQC) involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Serum sickness
Clinical narrative: This spontaneous report was received from a 39 year old female consumer via company representative referring to herself. The patient was not pregnant. She has a benign brain tumor, had radiation therapy a few years ago and had 3 healthy kids before the tumor was discovered. On 09-AUG-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (1 Dose once, route of administration and lot# were unknown). Concomitant therapies were not reported. On the same day, the patient experienced "serum sickness", had a fever of up to "105 degrees" and was rushed to an unspecified ER (emergency room) for medical attention after receiving an unspecified pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccination. She was not admitted to the hospital. "She was feeling better today and was home". The outcome of the events were reported as recovering/resolving. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD which had lot # M003436, expiry date: 19-JUL-2017; lot # L050910, expiry date: 14-JUN-2017 and lot # M001664, expiry date: 08-SEP-2017 (route, dose and anatomical place of vaccination were not provided). The vaccines with lot # M003436 and lot # L050910 were exposed to temperature of 41 degree Fahrenheit for 10 hours. While the vaccine with lot # M011664 was exposed to 40 degree degree Fahrenheit for 8 hours. Also, the vaccine had previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed Practical Nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 08-AUG-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M002418, expiry date 12-JAN-2018 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ which had lot # L03545, expiry date: 30-MAY-2017 (route, dose and anatomical place of vaccination were not provided)This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates after 24-MAR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # K009105 with an expiry date 21-JAN-2016, doses, frequencies and route were not reported). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested. The vaccines were exposed to temperature of 74 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates after 24-MAR-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot # J016232 with an expiry date 19-DEC-2015, doses, frequencies and route were not reported. No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates after 24-MAR-2015 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (batch # K001957 with an expiry date 24-OCT-2016, doses, frequencies and route were not reported). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates after 24-MAR-2015, the patients were vaccinated with improperly stored doses of Gardasil (lot # K006447 with an expiry date 19-JUN-2016, doses, frequencies and route were not reported). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report concerning a patient of unknown gender and age was received from a physician. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot and expiration date were not provided), by intramuscular route. There were no concomitant medications reported. On an unknown date, the patient fainted (syncope). No product quality complain was involved. At the time of reporting, the outcome of the event of syncope was unknown. The causality between GARDASIL and the event of syncope was not assessed. Additional information is not expected as the reporter did no consent for follow-up attempts.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot/batch # L048849, expiry date 04-FEB-2018 (dose, strength, vaccination site and route unspecified). The temperature excursion was reported as 34F for 48 hours. No adverse effect were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL lot/batch # L033347, expiry date 23-JUL-2017 (dose, strength, vaccination site and route unspecified). The temperature excursion was reported as 34F for 48 hours. No adverse effect were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored MMR II (lot# M004889, expiration date 25-JUL-2017, dose not reported) subcutaneously and a dose of improperly stored VAQTA (lot# reported as L02374, expiration date 04-NOV-2016, dose not reported) intramuscularly. Two vaccines were improperly stored in 33 degrees Fahrenheit for 600 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Lot number L02374 is an invalid lot number for hepatitis a vaccine, inactivated. Additional information has been requested.
Sex: U
Vaccine: PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown date, an unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L003227 expiration 13-OCT-2016. Other therapies included ROTATEQ L047158 expiration 17-SEP-2017 (MARRS# 1608USA007206). The temperature was reported as 34F and time frame 15 hours 20 minutes. No symptoms were reported. No further information was provided. This is one of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose
Clinical narrative: A spontaneous report was received on 12-JUL-2016 via a phone message left from a company representative who was informed by a registered nurse that an unspecified patient received a pediatric dose of VAQTA (0.5ml) "2 years ago" at the age of "18 years old." The patient received a second dose of VAQTA (0.5ml) which was a "pediatric dose" on 12-JUL-2016 at the age of "20 years old," which is outside the recommendations in the VAQTA prescribing information. No adverse effect was reported. No further details were provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A spontaneous report was received on 13-JUL-2016 from a medical assistant who reported that a patient (age and gender not reported) was inadvertently administered one dose of PROQUAD (dose not reported) and one dose of VARIVAX (dose not reported), both on 13-JUL-2016 during an office visit. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot/batch # L040178, expiry date 18-AUG-2017 (dose, strength, vaccination site and route unspecified). The temperature excursion was reported as 34F for 48 hours. No adverse effect were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ lot/batch # L035511, expiry date 21-MAY-2017 (dose, strength, vaccination site and route unspecified). The temperature excursion was reported as 34F for 48 hours. No adverse effect were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown date, an unspecified number of patients were vaccinated with improperly stored ROTATEQ L047158 expiration 09/17/2017. Other therapies included PNEUMOVAX 23 lot # L003227 expiration 13-OCT-2016 (MARRS# 1607USA005549). The temperature was reported as 34 F and time frame of 15 hours 20 minutes. No symptoms were reported. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Complain arm pain with erythema and induration at site of injection 5 cm diameter.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient experienced redness and itching at injection site on right shoulder. This is believed to be from PNEUMOVAX.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Influenza virus test, Pain, Pyrexia, Somnolence
Clinical narrative: Generalized sore, achy 1 hr after vaccine. Fever to 102 degrees F 2 hrs after vaccine. Fever to 103.5 18 hrs after vaccine. Fever to 102 24-36 hrs after vaccine. Extremely sleepy, temp to 100 degrees F to present. No localizing symptoms.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: Generalized sore, achy 1 hr after vaccine. Fever to 102 degrees F 2 hrs after vaccine. Fever to 103.5 18 hrs after vaccine. Fever to 102 24-36 hrs after vaccine. Extremely sleepy, temp to 100 degrees F to present. No localizing symptoms.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Hypoaesthesia, Tremor
Clinical narrative: Lightheadedness, numbness (arms and legs), dizziness, Shakiness. Gave patient water and some food. Said she felt better, but the symptoms came back. Treated with hydroxyzine in the hospital.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Nausea
Clinical narrative: Severe nausea.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Fever of 100 F. Chills. Tiredness. Body aches. Pain in spine. Pain and stiffness in arm where vaccine received.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Spinal pain
Clinical narrative: Fever of 100 F. Chills. Tiredness. Body aches. Pain in spine. Pain and stiffness in arm where vaccine received.
Age: 0.5
Sex: F
Vaccine: DTAPH, HEP, IPV, PPV
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 0.42
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: Started to get high fever.
Age: 0.42
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Started to get high fever.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Headache, Photopsia, Pyrexia, Rash macular
Clinical narrative: Several rapid flashes of light followed by sever headache that has reduced to a dull ache for going on 4 days now. On the 2nd night 08/13/2016 at 7pm I noticed red blotches on my face. By the morning of 08/14/2016 at 6 am I had them on my stomach. I have had a runny nose for 2 days and a low grade fever of 99.3. The red blotches dont itch but they do burn and especially when I get hot or go outside in warm weather.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: Several rapid flashes of light followed by sever headache that has reduced to a dull ache for going on 4 days now. On the 2nd night 08/13/2016 at 7pm I noticed red blotches on my face. By the morning of 08/14/2016 at 6 am I had them on my stomach. I have had a runny nose for 2 days and a low grade fever of 99.3. The red blotches dont itch but they do burn and especially when I get hot or go outside in warm weather.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Injection site haemorrhage, Pruritus
Clinical narrative: Redness & itching that continually gets bigger each day on left arm. The redness has spread down to her forearm.  Patient is also experiencing what looks like petechiae around injection area. Patient is going to call doctor tomorrow (8/15) to try to be seen.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm became warm to the touch, red, and swollen from the site of injection to past elbow several hours after injection.  Patient used cold compress and Benadryl cream to help with the inflammation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: Swelling, redness, pain of left thigh at injection site; used ibuprofen and ice with minimal relief.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Severe Pain, Swelling, Redness Near Injection Site, Stiffness in Right Arm, Headache, Tiredness.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Severe Pain, Swelling, Redness Near Injection Site, Stiffness in Right Arm, Headache, Tiredness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Started breaking out in hives underarm and then to leg and back.  She said there was a lot of itching. She went to see ER. doctor on 8/13/2016.  Doctor prescribed prednisone and Benadryl.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Agitation, Crying, Erythema, Insomnia, Irritability
Clinical narrative: Hives, welts, redness, difficulty sleeping, irritated, crying, itchiness, agitated. The hives, welts, redness, and gigantic skin blotches kept appearing in different places such as ears, underarms, behind knees, ankles, foot, ears, neck, stomach, in between his inner thighs near the pens, in his buttocks area.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Hives, welts, redness, difficulty sleeping, irritated, crying, itchiness, agitated. The hives, welts, redness, and gigantic skin blotches kept appearing in different places such as ears, underarms, behind knees, ankles, foot, ears, neck, stomach, in between his inner thighs near the pens, in his buttocks area.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Lethargy, Pain, Pyrexia, Screaming
Clinical narrative: Lethargic, no appetite, throwing up at 2:30 PM, again 10:30 PM.  Fever 104 (rectal) 11:30 PM continued through next day. Fever drop to 102/103 7/16/2016 continued for 2 days.  Lethargy and no appetite also continued for same period.  Unable to keep even liquids down, would throw up within 10 minutes of trying to ingest anything. From 7/14/2016 through 7/18/2016 child would randomly scream as though in pain.  Sometimes while sleeping, or just sitting/standing.  No explanation and no contributing factors. No medications were given during this time.  Baths given to reduce or help with fever.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Lethargic, no appetite, throwing up at 2:30 PM, again 10:30 PM.  Fever 104 (rectal) 11:30 PM continued through next day. Fever drop to 102/103 7/16/2016 continued for 2 days.  Lethargy and no appetite also continued for same period.  Unable to keep even liquids down, would throw up within 10 minutes of trying to ingest anything. From 7/14/2016 through 7/18/2016 child would randomly scream as though in pain.  Sometimes while sleeping, or just sitting/standing.  No explanation and no contributing factors. No medications were given during this time.  Baths given to reduce or help with fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX which had the lot # L049536, expiry date: 08-DEC-2017; lot # L044526, expiry date: 09-NOV-2017 and L037562, expiry date: 29-SEP-2017 (route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccines were exposed to temperature of 41 degree Fahrenheit for 10 hours. The temperature excursion was detected by a date logger. At the tie of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates after 24-MAR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # K009105 with an expiry date 21-JAN-2016, doses, frequencies and route were not reported). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. The patient was vaccinated with GARDASIL first dose on 20-AUG-2012, the second dose on 10-JUL-2013, the third dose on 30-DEC-2013 (lot#, expiration, dose, frequency and route were unspecified) (onset approximated to 2013). On 28-JUL-2016, the patient inadvertently received an additional dose of GARDASIL 9 (Lot# L024993 with an expiry date 17-OCT-2017) (dose, frequency and route were not reported). No adverse effect was reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies of patients were not reported. On 02-AUG-2016, the patients were vaccinated with warm VARIVAX injection (doses, frequencies and lot# not reported) subcutaneously after shipment was received. The agency advised her today that VARIVAX vaccine should not be administered. No patients have reported adverse effects. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Ultrasound abdomen normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a licensed practical nurse regarding a 19 year old female patient. "Around April 2016," the patient was vaccinated with GARDASIL (dose number, dosage, formulation, lot number, expiration date, and route of administration unknown). The patient took at home pregnancy tests on 27-JUN-2016 and 28-JUN-2016 (results not reported), then called the office on 29-JUN-2016 to schedule an appointment. An abdominal ultrasound performed on 14-JUL-2016 determined the pregnancy gestation to be 15 weeks and 4 days. Last menstrual period was therefore calculated by subtracting 15 weeks and 4 days form 14-JUL-2016 and determined to be 27-MAR-2016, with estimated date of delivery of 01-JAN-2017. The outcome of the vaccine exposure during pregnancy was unknown as the outcome of the pregnancy is pending. No further details provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a male patient of unknown age. There was no information provided regarding the patient's medical history or concurrent conditions. On 19-Jul-2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19,400 PFU, lot # L012477, expiration date 10-JUL-2016 (route of administration not provided). Concomitant medications were not reported. No adverse effect was reported. The outcome for the expired dose of ZOSTAVAX is unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2016, the patient was vaccinated with expired dose of M-M-R II which had lot# J006955, expiry date: 07-JUN-2015 (dose and route not reported). No adverse reactions were reported. No further information was provided. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, an expired dose of M-M-R II (rHA, lot # K010319, expiration date 22-JUL-2016; dose and route were unknown) was inadvertently administered to the patient. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On 02-AUG-2016, the patients might have received improperly stored and then expired doses of ROTATEQ (lot # K022995, expiration date 22-JUL-2016, dose not reported) orally. On 08-JUL-2016, the vaccine was improperly stored at 49.1 degree Fahrenheit for 1 hour 7 minutes. There was no previous excursion. Data logger was involved. No adverse effects were reported. The nurse had requested stability data for ROTATEQ for the excursion that occurred prior to expiration. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot # L021602 10-SEP-2016, L025001 06-OCT-2016, L036445 22-DEC-2016, L037797 30-DEC-2016, L048452 01-MAR-2017, M010472 01-JUN-2017. No adverse effects were reported. Temperature -13.3 degrees centigrade, time 10 minutes. There was no previous exposure. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Paralysis
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Albumin CSF normal, Anal sphincter atony, Angiogram normal, Antithrombin III decreased, Areflexia
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Back pain, Blood glucose normal, Blood test normal, Borrelia test negative, CSF immunoglobulin decreased
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: CSF immunoglobulin increased, CSF oligoclonal band absent, CSF protein normal, CSF test normal, Computerised tomogram abdomen normal
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Computerised tomogram pelvis, Computerised tomogram thorax normal, Constipation, Cytomegalovirus test negative, Dysaesthesia
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Herpes simplex test negative, Hypertension, Hypoaesthesia, Hypogammaglobulinaemia, Muscular weakness
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Pain, Paraesthesia
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Paraplegia, Rash, Sensory loss, Treponema test negative, Viral infection
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Age: 53.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Viral test negative, Wheelchair user
Clinical narrative: Informed by patient's wife on 8/11/16 that pt started to become paralyzed 32 days after receiving MMR vaccine from the clinic and was diagnosed with Possible Inflammatory Acute Transverse Myelitis. Pt's wife stating that reason unknown but after researching and thinking possible from MMR vaccine d/t multiple researching.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2016, the patient was vaccinated with an expired ZOSTAVAX vial (lot # K010967 with expiry date 11-JUN-2015, dose and route unknown). The patient did not have any adverse effects. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Age: 28.0
Sex: F
Vaccine: HEPAB, JEV, TYP, HEPAB, JEV, TYP
Symptoms: Asthenia, Computerised tomogram head normal, Dehydration, Full blood count normal, Headache
Clinical narrative: Within 10 minutes of receiving Twinrix, JEV and Typhoid vaccine pt c/o headache and vomiting. Pt reported vomiting for 2 hours after the administration of the vaccines. Pt felt so bad went to ER later in evening after calling the advice nurse.
Age: 28.0
Sex: F
Vaccine: HEPAB, JEV, TYP, HEPAB, JEV, TYP
Symptoms: Metabolic function test abnormal, Retching, Vomiting
Clinical narrative: Within 10 minutes of receiving Twinrix, JEV and Typhoid vaccine pt c/o headache and vomiting. Pt reported vomiting for 2 hours after the administration of the vaccines. Pt felt so bad went to ER later in evening after calling the advice nurse.
Age: 28.0
Sex: F
Vaccine: HEPAB, JEV, TYP, HEPAB, JEV, TYP
Symptoms: Headache, Vomiting
Clinical narrative: Within 10 minutes of receiving Twinrix, JEV and Typhoid vaccine pt c/o headache and vomiting. Pt reported vomiting for 2 hours after the administration of the vaccines. Pt felt so bad went to ER later in evening after calling the advice nurse.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Constipation, Myelitis transverse, Urinary retention
Clinical narrative: Probable transverse myelitis.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Lumbar puncture normal, Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic abnormal
Clinical narrative: Probable transverse myelitis.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Abasia, Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, Borrelia test negative
Clinical narrative: Subjective weakness in legs with inability to ambulate and burning sensation in upper legs and shoulders.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Burning sensation, C-reactive protein normal, CSF test normal, Computerised tomogram head normal, Electromyogram normal
Clinical narrative: Subjective weakness in legs with inability to ambulate and burning sensation in upper legs and shoulders.