chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site swelling, Nasal congestion, Pyrexia, Rash papular
Clinical narrative: Papulovesicular rases (scattered lesion) noted on 3/12/15 (10 days after immunization). Fever with rash and nasal congestion. Erythematous some time swelling at swelling of injection also noted on 3/11/15.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm was swollen and red for several weeks. Patient used cool compresses and BENADRYL and symptoms have subsided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 02-JAN-2015, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Patient had a history of shingles and she had a very sensitive skin. All pertinent medical history occurred prior to the ZOSTAVAX. Patient did not have drug allergies. About a year ago in 2014, the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous (lot # and expiry date unspecified). Concomitant medications included unspecified blood pressure medications. Within 24 hours of receiving the vaccine, she developed redness, swelling, and blistery looking things broke out around the injection site. On an unspecified date, the patient went to the pharmacy to show the symptoms that she developed. She was informed to take BENADRYL for the events. No lab tests were performed. The reporting pharmacist also stated that on unspecified dates she administered an unspecified amount of doses of ZOSTAVAX to an unspecified amount of patients who had a previous history of shingles. No adverse effects were reported for these unspecified patients. The female patient recovered from the events about 3 or 4 days later after developing the symptoms. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On 07-OCT-2014 the patient was vaccinated with M-M-R II which underwent a temperature excursion. No adverse event was reported. This is one of several reports from same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site mass, Injection site warmth, Rash, Rash pruritic
Clinical narrative: 48 hrs. after vaccine, (R) deltoid was hot to touch, hard lump, rash down upper arm that conitnued to spread til 36 hrs later. Itchy rash still present, though lighter, 8 days later took BENADRYL 25 mg to relieve itchiness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Rash, Rash erythematous, Swelling
Clinical narrative: Woke with rash, swollen, red raised bumps (tiny) closely grouped together down to elbow. (R) arm. Next day, other arm, (L) arm, but "less intense". Slept a lot over the weekend. Fever - unknown. 3/23/15 rash less red, less swollen, energy better.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of adult patients (gender and exact age were not provided). The patients' relevant medical history and concomitant medication were not provided. On an unknown date, the patients were vaccinated with 1ml dose of VAQTA (route, lot# and expiration date were not reported) using two combined pediatric doses of VAQTA. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left posterior-lateral mid upper arm with about 2x3 cm red, warm site, non tender. Well demarcaated area of involvement with no red extending from area with full ROM of arm.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Ocular discomfort, Peripheral swelling, Throat irritation
Clinical narrative: Pt c/o scratchy throat, pressure behind eyes, headache, hands were swelling. Was given DECADRON 4mg IM and advised BENADRYL as well.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling, Type III immune complex mediated reaction
Clinical narrative: Erythema, raised, hot to touch, sore center area of red location had a lighter discoloration. Appearance of an arthus-like reaction.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient. No medical history or concurrent conditions were provided. On 03-Mar-2015, the patient was vaccinated with his second dose of (Oka/Merck) VARIVAX (lot number reported as K016127; expiration date not reported), subcutaneously (dose not provided). No co-suspect or concomitant therapies were provided. On 04-MAR-2015, the patient experienced localized redness and swelling, and pyrexia for three days. Approximately on 07-MAR-2015, the patient recovered from pyrexia. At the time od the report, the outcome of the events local swelling and erythema was unknown. The causality was not provided. This case is linked to case MARRS # 1107USA02800 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients received an unspecified number of improperly stored doses of VARIVAX (subcutaneous, dose and lot number not provided) on unspecified dates since 25-JAN-2015. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 0.5 ml, intramuscular (dose # unknown) post supported excursion (incorrect product storage). Nurse was not able to say which lot number the administered PNEUMOVAX23 dose came from (Lot K006681, Exp. 21-OCT-2015 and Lot K018528, Exp. 14-APR-2016 were both involved in supported excursion). No adverse effects reported. No product quality issue (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an immunization official healthcare worker referring to multiple unspecified patients of unknown age. On an unknown date the multiple unspecified patients was vaccinated with GARDASIL (dose, frequency, route and lot# were not reported), which were stored improperly. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients. Sometime in the month of February 2015, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K016425, expiration date: 26-MAR-2016, dose and route were not reported). No symptoms were reported. The nurse did not have patients' identification information available at the time of reporting. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received FLUARIX QUADRIVALENT (batch number DJ395, expiry date 30th June 2015). Previously administered products included influenza vaccination with an associated reaction of pain in extremity (for 6 months (see case US2015GSK039815)). Concurrent medical conditions included penicillin allergy, drug allergy and iodine allergy. On 5th December 2014, the patient received FLUARIX QUADRIVALENT 1 ml. On 5th December 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm, shoulder pain and injection site reaction. On an unknown date, the outcome of the pain in arm, shoulder pain and injectio site reaction were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shoulder pain and injection site reaction to be related to FLUARIX QUADRIVALENT.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: 10/8: Received Flu Vaccine. 10/10: Developed left sided neck and shoulder pain. 10/20: Saw provider for symptoms. Neck x-ray done. No abnormalities present. 10/22: Left arm numbness began. Saw provider and cervical MRI done. No abnormalities present. 10/23: Unable to lift left arm above chest. Saw ortho provider and did shoulder MRI. 10/24: Symptoms continued. 10/25: Admitted to hospital for pain control and diagnostics. 10/27: Given diagnosis of vaccine induced Parsonage-Turner Syndrome.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal normal, Spinal X-ray normal, Vaccination complication
Clinical narrative: 10/8: Received Flu Vaccine. 10/10: Developed left sided neck and shoulder pain. 10/20: Saw provider for symptoms. Neck x-ray done. No abnormalities present. 10/22: Left arm numbness began. Saw provider and cervical MRI done. No abnormalities present. 10/23: Unable to lift left arm above chest. Saw ortho provider and did shoulder MRI. 10/24: Symptoms continued. 10/25: Admitted to hospital for pain control and diagnostics. 10/27: Given diagnosis of vaccine induced Parsonage-Turner Syndrome.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to a 25 year old female patient with polycystic ovary syndrome, PCN allergy, endometriosis, hypertension, migraines, smoker and obesity. The physician reported that on 04-NOV-2014 the patient was vaccinated with GARDASIL. Concomitant therapies included Prenatal Vitamins. The physician stated that the patient took a home urine pregnancy test on 20-NOV-2014 and the result was positive. The physician reported that the patient was seen in the office today and that the patient is "about six weeks pregnant." The LMP and EDD is not known. The outcome of vaccine exposure during pregnancy is unknown. No further information was provided. Follow-up information has been received on 23-MAR-2015 from a registered nurse, concerning the woman patient. It was reported, that the Last Menstrual Period (LMP) was on 10-OCT-2014, the estimated date of conception on 10-NOV-2014 and the estimated date of delivery on 04-AUG-2015 (reported as 04-AUG-2014). The patient's current condition included also a borderline personality, depression, asthma, chronic HA, hypothyroid. The patient had a FOB xh. ibp II 2 deletion syndrome. The patient quitted smoking on approximately DEC-2014. It was reported, that the patient "drinks 6 cans beer at pregnancy". The patient's BMI was >40. On 04-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular in left deltoid, Lot # J009788, expiration date 04-FEB-2015). The patient was one week and one day pregnant at the time of vaccination. On 23-NOV-2014, urine pregnancy test was performed with positive result. On 08-DEC-2014, the following labs were performed: ABO/RH (blood grouping) with the result O RH+ and glucose (blood glucose) with the result 147 (units not provided). On 03-MAR-2015, the patient was hospitalized because of HTN and was diagnosed on the next date (04-MAR-2015). On 10-MAR-2015 (19 weeks pregnant), ultrasound was performed, with the result WDL (within defined limits). During pregnancy the patient was taking the following medicines: levothyroxine (from 09-DEC-2014) for hypothyroid, meclizine hydrochloride/pyridoxine hydrochloride (PNV) (from 09-DEC-2014), aspirin (from 20-FEB-2015) for preeclampsia, FIORICET (from 04-MAR-2015) for migraines, ALDOMET (from 06-MAR-2015) for hypertension. The outcome of adverse events was unknown. The relatedness between hypertension aggravated and therapy with GARDASIL was not reported. Additional information has been requested. Reporters details, patient and product details, event details and analysis were updated.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Condition aggravated, Exposure during pregnancy, Hypertension, Pre-eclampsia
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to a 25 year old female patient with polycystic ovary syndrome, PCN allergy, endometriosis, hypertension, migraines, smoker and obesity. The physician reported that on 04-NOV-2014 the patient was vaccinated with GARDASIL. Concomitant therapies included Prenatal Vitamins. The physician stated that the patient took a home urine pregnancy test on 20-NOV-2014 and the result was positive. The physician reported that the patient was seen in the office today and that the patient is "about six weeks pregnant." The LMP and EDD is not known. The outcome of vaccine exposure during pregnancy is unknown. No further information was provided. Follow-up information has been received on 23-MAR-2015 from a registered nurse, concerning the woman patient. It was reported, that the Last Menstrual Period (LMP) was on 10-OCT-2014, the estimated date of conception on 10-NOV-2014 and the estimated date of delivery on 04-AUG-2015 (reported as 04-AUG-2014). The patient's current condition included also a borderline personality, depression, asthma, chronic HA, hypothyroid. The patient had a FOB xh. ibp II 2 deletion syndrome. The patient quitted smoking on approximately DEC-2014. It was reported, that the patient "drinks 6 cans beer at pregnancy". The patient's BMI was >40. On 04-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular in left deltoid, Lot # J009788, expiration date 04-FEB-2015). The patient was one week and one day pregnant at the time of vaccination. On 23-NOV-2014, urine pregnancy test was performed with positive result. On 08-DEC-2014, the following labs were performed: ABO/RH (blood grouping) with the result O RH+ and glucose (blood glucose) with the result 147 (units not provided). On 03-MAR-2015, the patient was hospitalized because of HTN and was diagnosed on the next date (04-MAR-2015). On 10-MAR-2015 (19 weeks pregnant), ultrasound was performed, with the result WDL (within defined limits). During pregnancy the patient was taking the following medicines: levothyroxine (from 09-DEC-2014) for hypothyroid, meclizine hydrochloride/pyridoxine hydrochloride (PNV) (from 09-DEC-2014), aspirin (from 20-FEB-2015) for preeclampsia, FIORICET (from 04-MAR-2015) for migraines, ALDOMET (from 06-MAR-2015) for hypertension. The outcome of adverse events was unknown. The relatedness between hypertension aggravated and therapy with GARDASIL was not reported. Additional information has been requested. Reporters details, patient and product details, event details and analysis were updated.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test urine positive, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to a 25 year old female patient with polycystic ovary syndrome, PCN allergy, endometriosis, hypertension, migraines, smoker and obesity. The physician reported that on 04-NOV-2014 the patient was vaccinated with GARDASIL. Concomitant therapies included Prenatal Vitamins. The physician stated that the patient took a home urine pregnancy test on 20-NOV-2014 and the result was positive. The physician reported that the patient was seen in the office today and that the patient is "about six weeks pregnant." The LMP and EDD is not known. The outcome of vaccine exposure during pregnancy is unknown. No further information was provided. Follow-up information has been received on 23-MAR-2015 from a registered nurse, concerning the woman patient. It was reported, that the Last Menstrual Period (LMP) was on 10-OCT-2014, the estimated date of conception on 10-NOV-2014 and the estimated date of delivery on 04-AUG-2015 (reported as 04-AUG-2014). The patient's current condition included also a borderline personality, depression, asthma, chronic HA, hypothyroid. The patient had a FOB xh. ibp II 2 deletion syndrome. The patient quitted smoking on approximately DEC-2014. It was reported, that the patient "drinks 6 cans beer at pregnancy". The patient's BMI was >40. On 04-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular in left deltoid, Lot # J009788, expiration date 04-FEB-2015). The patient was one week and one day pregnant at the time of vaccination. On 23-NOV-2014, urine pregnancy test was performed with positive result. On 08-DEC-2014, the following labs were performed: ABO/RH (blood grouping) with the result O RH+ and glucose (blood glucose) with the result 147 (units not provided). On 03-MAR-2015, the patient was hospitalized because of HTN and was diagnosed on the next date (04-MAR-2015). On 10-MAR-2015 (19 weeks pregnant), ultrasound was performed, with the result WDL (within defined limits). During pregnancy the patient was taking the following medicines: levothyroxine (from 09-DEC-2014) for hypothyroid, meclizine hydrochloride/pyridoxine hydrochloride (PNV) (from 09-DEC-2014), aspirin (from 20-FEB-2015) for preeclampsia, FIORICET (from 04-MAR-2015) for migraines, ALDOMET (from 06-MAR-2015) for hypertension. The outcome of adverse events was unknown. The relatedness between hypertension aggravated and therapy with GARDASIL was not reported. Additional information has been requested. Reporters details, patient and product details, event details and analysis were updated.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chills, Laboratory test, Pain
Clinical narrative: This is a spontaneous report from a clinical supervisor at doctor's office. A 79-year-old male patient of an unspecified ethnicity received PREVNAR 13 (lot # J20348, exp date 11May2016, NDC 0000519710) intramuscular to right deltoid at 0.5 ml, single on 13Mar2015 morning at the doctor's office. Medical history included benign prostatic hyperplasia, hyperlipidaemia, hypertension, obstructive sleep apnoea syndrome, thrombophlebitis popliteal vein, actinic keratosis from an unknown date and unknown if ongoing. Concomitant medication included aspirin 81mg daily, atenolol 50mg 1 tablet in morning, CORICIDIN D as needed OTC for sinus pressure, finasteride 5mg orally once a day, tamsulosin HCl 0.4mg once a day, METAMUCIL as needed for stomach extra fiber constipation, Vitamin D3 2000 units oral capsule one daily. While the patient was in doctor's office there were no complaints at the time. The patient's wife called the reporter at 5:40 pm on 13Mar2015 stating that he was having chills, shakes and entire body was hurting. The wife spoke with nursing staff in a 3rd party call center and they sent him to the emergency room with 105 fever. The temperature was taken at home. The patient's family called the doctor's office after hours and was advised to go to the emergency room with a 105 temperature on 13Mar2015. The patient was hospitalized for the events from 13Mar2015. The patient underwent lab tests and procedures which included body temperature increased: 105 on 13Mar2015. The outcome of the event chills is ongoing, the outcome of the events of shakes, and entire body hurting is ongoing. The outcome of the event fever was unknown. Patient was still in hospital. The reporter stated that they pulled all of that particular lot number from the building and a variance report was done. This office has not had any other complaints on this lot. PREVNAR 13.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a clinical supervisor at doctor's office. A 79-year-old male patient of an unspecified ethnicity received PREVNAR 13 (lot # J20348, exp date 11May2016, NDC 0000519710) intramuscular to right deltoid at 0.5 ml, single on 13Mar2015 morning at the doctor's office. Medical history included benign prostatic hyperplasia, hyperlipidaemia, hypertension, obstructive sleep apnoea syndrome, thrombophlebitis popliteal vein, actinic keratosis from an unknown date and unknown if ongoing. Concomitant medication included aspirin 81mg daily, atenolol 50mg 1 tablet in morning, CORICIDIN D as needed OTC for sinus pressure, finasteride 5mg orally once a day, tamsulosin HCl 0.4mg once a day, METAMUCIL as needed for stomach extra fiber constipation, Vitamin D3 2000 units oral capsule one daily. While the patient was in doctor's office there were no complaints at the time. The patient's wife called the reporter at 5:40 pm on 13Mar2015 stating that he was having chills, shakes and entire body was hurting. The wife spoke with nursing staff in a 3rd party call center and they sent him to the emergency room with 105 fever. The temperature was taken at home. The patient's family called the doctor's office after hours and was advised to go to the emergency room with a 105 temperature on 13Mar2015. The patient was hospitalized for the events from 13Mar2015. The patient underwent lab tests and procedures which included body temperature increased: 105 on 13Mar2015. The outcome of the event chills is ongoing, the outcome of the events of shakes, and entire body hurting is ongoing. The outcome of the event fever was unknown. Patient was still in hospital. The reporter stated that they pulled all of that particular lot number from the building and a variance report was done. This office has not had any other complaints on this lot. PREVNAR 13.
Sex: U
Vaccine: HPV4, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient were not reported. On 03-DEC-2014 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient were not reported. On 03-DEC-2014 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at the site of administration.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Bronchiolitis, Dyspnoea, Gastroenteritis, Pneumonia
Clinical narrative: AS STATED IN ONLINE INFO....EXCEPT I AM NOT A Toddler ....The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%) BOTH TIMES I GOT IT AND COULD HARDLY BREATHE.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Joint range of motion decreased, Malaise, Mobility decreased
Clinical narrative: Within an hour or 2 of receiving the vaccine she started not feeling well in general, like she was coming down with something. She also started feeling pain in her shoulder, up to the neck and down the arm to the elbow. As the day progressed the pain became worse and she couldn't move her arm at all. This lasted for 2 days. The reaction started to subside by 3/26/15 and she could move her arm a little, but still does not have full ROM. Spoke to patient on 3/27/15. She continued to have low energy through 3/26 but feels better today. The arm is still tender to touch, but she has full ROM and her energy is better.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Within an hour or 2 of receiving the vaccine she started not feeling well in general, like she was coming down with something. She also started feeling pain in her shoulder, up to the neck and down the arm to the elbow. As the day progressed the pain became worse and she couldn't move her arm at all. This lasted for 2 days. The reaction started to subside by 3/26/15 and she could move her arm a little, but still does not have full ROM. Spoke to patient on 3/27/15. She continued to have low energy through 3/26 but feels better today. The arm is still tender to touch, but she has full ROM and her energy is better.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, TD
Symptoms: Rash, Rash erythematous, Rash pruritic, Swelling face
Clinical narrative: Red, itchy pea sized bumps on nose, cheek, forehead, left wrist and right palm. Left side of face was swollen.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a head nurse in physician assistant office via the field representative refers to a male patient of age approximately 2 years. Concurrent conditions and medical history was not reported. In approximately 2013 (single dose given at 2, 4 and 6 months of age) the patient was vaccinated with ROTATEQ who received all series of doses (lot number, dose, frequency, route of administration not reported). Concomitant medications were not reported. On an unknown date, the patient had rotavirus infection after receiving the full series of ROTATEQ unknown date. The outcome of rotavirus infection was reported as not reported. No further information related to the patient symptoms has been provided. Causality assessment was not reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Swelling at site, hives all over body.
Age: 1.46
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: Injection site erythema, Pyrexia, Rash
Clinical narrative: Rash, Red Spot, and Fever.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Amnesia, Chest discomfort, Chest pain, Consciousness fluctuating, Fatigue
Clinical narrative: Blurred eye vision, tight throat and chest, extreme fatigue, chest pain, numbness, headache, in and out of consciousnesses, heart racing, memory losses, 2 shots of EPI- Pens, ICU Hospital Stay. Ambulance was called and I was on oxygen when I came to at Hospital Benadryl and Pepcid, also administered. See medical records which I will send when Doctors have filed them and finished them. So much happened.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Intensive care, Palpitations, Throat tightness
Clinical narrative: Blurred eye vision, tight throat and chest, extreme fatigue, chest pain, numbness, headache, in and out of consciousnesses, heart racing, memory losses, 2 shots of EPI- Pens, ICU Hospital Stay. Ambulance was called and I was on oxygen when I came to at Hospital Benadryl and Pepcid, also administered. See medical records which I will send when Doctors have filed them and finished them. So much happened.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Vision blurred
Clinical narrative: Blurred eye vision, tight throat and chest, extreme fatigue, chest pain, numbness, headache, in and out of consciousnesses, heart racing, memory losses, 2 shots of EPI- Pens, ICU Hospital Stay. Ambulance was called and I was on oxygen when I came to at Hospital Benadryl and Pepcid, also administered. See medical records which I will send when Doctors have filed them and finished them. So much happened.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood pressure decreased, Blood pressure increased, Dysgeusia, Lethargy, Throat tightness
Clinical narrative: Blurred eye vision, tight throat and chest, extreme fatigue, chest pain, numbness, headache, in and out of consciousnesses, heart racing, memory losses, 2 shots of EPI- Pens, ICU Hospital Stay. Ambulance was called and I was on oxygen when I came to at Hospital Benadryl and Pepcid, also administered. See medical records which I will send when Doctors have filed them and finished them. So much happened.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: There is no adverse event. This report is done because of the request of CDC staff memeber. What happened is patient was supposed to get Hep B dialysis dose which is 40 mcg. Our clinic has 20 mcg/ml in vial and pt was given 1 shot which is half of the dose that he was supposed to receive.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain, Asthma, Blood test, Chills, Computerised tomogram abdomen abnormal
Clinical narrative: Female patient received Td in early December, 2014 due to stepping on a nail. On the same day as vaccination, the patient felt throat swelling, inner ear itching, asthma, woozy, and fainting. Patient took prednisone for about one week. When she stopped taking prednisone, she felt that the same symptoms worsened, and she also experienced high blood pressure, diarrhea, vomiting, high heart rate, fever, and chills. Patient was transported to the hospital, by an ambulance. She was hospitalized for 2 days, 12/11/14 - 12/12/14. The hospital performed unknown blood tests and a CT scan showing an enlarged spleen. Patient has not recovered; she has abdominal pain and an abscess tooth.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Dizziness, Ear pruritus, Heart rate increased, Hypertension
Clinical narrative: Female patient received Td in early December, 2014 due to stepping on a nail. On the same day as vaccination, the patient felt throat swelling, inner ear itching, asthma, woozy, and fainting. Patient took prednisone for about one week. When she stopped taking prednisone, she felt that the same symptoms worsened, and she also experienced high blood pressure, diarrhea, vomiting, high heart rate, fever, and chills. Patient was transported to the hospital, by an ambulance. She was hospitalized for 2 days, 12/11/14 - 12/12/14. The hospital performed unknown blood tests and a CT scan showing an enlarged spleen. Patient has not recovered; she has abdominal pain and an abscess tooth.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Pharyngeal oedema, Pyrexia, Splenomegaly, Syncope, Tooth abscess
Clinical narrative: Female patient received Td in early December, 2014 due to stepping on a nail. On the same day as vaccination, the patient felt throat swelling, inner ear itching, asthma, woozy, and fainting. Patient took prednisone for about one week. When she stopped taking prednisone, she felt that the same symptoms worsened, and she also experienced high blood pressure, diarrhea, vomiting, high heart rate, fever, and chills. Patient was transported to the hospital, by an ambulance. She was hospitalized for 2 days, 12/11/14 - 12/12/14. The hospital performed unknown blood tests and a CT scan showing an enlarged spleen. Patient has not recovered; she has abdominal pain and an abscess tooth.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Female patient received Td in early December, 2014 due to stepping on a nail. On the same day as vaccination, the patient felt throat swelling, inner ear itching, asthma, woozy, and fainting. Patient took prednisone for about one week. When she stopped taking prednisone, she felt that the same symptoms worsened, and she also experienced high blood pressure, diarrhea, vomiting, high heart rate, fever, and chills. Patient was transported to the hospital, by an ambulance. She was hospitalized for 2 days, 12/11/14 - 12/12/14. The hospital performed unknown blood tests and a CT scan showing an enlarged spleen. Patient has not recovered; she has abdominal pain and an abscess tooth.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Muscular weakness, Neuralgic amyotrophy
Clinical narrative: Patient came into public health clinic on 3/27/2015 to receive a print out of a flu shot that was administered by our office on 1/20/2014.  Patient reported he developed left arm and shoulder weakness, pain and loss of motion after receiving the flu shot and had been diagnosed with Parsonage-Turner Syndrome.  He reported this occurred after getting the vaccination and he was unable to work for several weeks and required physical therapy.  He reports he is still unable to have full range of motion of his left arm/shoulder.  Unknown if a previous VAERS report has been filed.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient came into public health clinic on 3/27/2015 to receive a print out of a flu shot that was administered by our office on 1/20/2014.  Patient reported he developed left arm and shoulder weakness, pain and loss of motion after receiving the flu shot and had been diagnosed with Parsonage-Turner Syndrome.  He reported this occurred after getting the vaccination and he was unable to work for several weeks and required physical therapy.  He reports he is still unable to have full range of motion of his left arm/shoulder.  Unknown if a previous VAERS report has been filed.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Body aches/fatigue followed by hot red hard swollen area over injection site on right upper arm lasting until 3-24-15. On 3-25 her LEFT hand began to swell and body aches returned and she described the pain as 10 out of 10 on 3-26. She called her regular doctor today but could not be seen. They thought it could be a reaction to the Tdap given 3-20-15 and told her to call the health dept to report it.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Peripheral swelling
Clinical narrative: Body aches/fatigue followed by hot red hard swollen area over injection site on right upper arm lasting until 3-24-15. On 3-25 her LEFT hand began to swell and body aches returned and she described the pain as 10 out of 10 on 3-26. She called her regular doctor today but could not be seen. They thought it could be a reaction to the Tdap given 3-20-15 and told her to call the health dept to report it.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Feeling hot, Pruritus
Clinical narrative: Redness, warmth, itching, discomfort.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Chills, Feeling abnormal, Feeling cold, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself and from another contactable consumer (patient wife). A 71-year-old male patient received the first single dose of PREVNAR 13 via an unspecified route of administration on 05Feb2015. Relevant medical history included acid reflux for which he took an unspecified medication, high blood cholesterol, atrial fibrillation, osteoarthritis for which he took an unspecified medication, ongoing schizophrenia. Concomitant medications included: GEODON at 40 mg twice a day for schizophrenia, trazodone, REMERON, PRADAXA at 150 mg twice a day for atrial fibrillation, CARDIZEM at 240 mg in the morning for atrial fibrillation, pravastatin for high blood cholesterol, all ongoing. On 05Feb2015, twenty minutes after the vaccination, the patient started to feel cold and to experience chills and he also felt 10 feet tall. The patient was hospitalized due to the event "he felt 10 feet tall" for 12 hours and received treatment for vertigo. No treatment given for events feel cold and chills. The patient added that he had schizophrenia and he did not know if that was why he felt 10 feet tall when he received the vaccination. The patient wife reported that he had lot of blood work during a previous hospitalization but she did not have the printouts of the blood test results and that the hospital could provide that information. Patient recovered from all the events on an unknown date. Follow up (11Mar2015): New information received from the same contactable consumer includes: seriousness, concomitant details, outcomes updated.
Age: 1.89
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Pt began to have swelling & redness to injection site several hours after receiving vaccine.  When seen in office she had 3.5cm area of erythema that was warm to touch and had mild induration.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Infant was given Rotavirus vaccine IM, instead of PO.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Rash generalised
Clinical narrative: Rash all over her body.
Age: 54.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient had significant swelling, redness, and pain at the injection site 2 days after vaccination. The injection site was firm to the touch and was still growing at the time.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Amnesia, Anxiety, Fatigue, Feeling abnormal
Clinical narrative: Daughter woke up trembling but could not move or yell out for help. Also felt fatigued, headache, and for the past year is still suffering since vaccination.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Muscular weakness, Rash, Seizure, Tremor
Clinical narrative: Daughter woke up trembling but could not move or yell out for help. Also felt fatigued, headache, and for the past year is still suffering since vaccination.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Site sensitive to touch, then raised red rash and itching.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient with severe soreness, swelling, induration, erythema, and pain in right deltoid region after Pneumovax 23 vaccination. Never before reacted to immunization. No crepitus. Patient was treated with hydrocortisone and subsequent prednisone. Pneumovax was added to allergies.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient states that at 9am on 3/27/15 she noticed that the site of injection was red, swollen and hot about the size of a quarter. By the afternoon when she presented to the pharmacy the injection site to larger to about an inch wide. Patient followed up with primary care doctor.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown date the patients were vaccinated with doses of improperly stored ROTATEQ (route oral, dose, dose number and lot # were not reported) or GARDASIL (dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. Concomitant therapy was not reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Ecchymosis, Erythema, Induration, Pain, Skin warm
Clinical narrative: Pt presented to clinic (six) days s/p vaccine administration. Pt presented = large area of induration. Minimal erythema and no drainage. (+) pain. (+) ecchymosis. (+) warmth.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. medical history and concurrent conditions were not reported. The register nurse informed nurse informed that on an unknown date the patients received improperly stored, ROTATEQ, oral (strength, dosage, lot# and expiration date were not reported). No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Head injury, Loss of consciousness, Neck pain
Clinical narrative: Pt received HPV vaccine. After pt sat for approx 10 mins she stood up and passed out. PT hit head, treated with ice, supine for aprox 45 mins. ED eval for neck pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Pruritus, Urticaria
Clinical narrative: Vaccine administered 3/17/15, on 3/18/15 patient had area of erythema/wheal about size of a quarter. On 3/20/15 patient had extension of erythema to about 5 cm x 5.5 cm, pruritic, generalized achiness.
Age: 0.69
Sex: M
Vaccine: DTP, HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 8-month-old male patient who received DTaP vaccine. Co-suspect products included HAVRIX 720 Junior and ENGERIX B PEDIATRIC (batch number unknown, expiry date 6th February 2015) and (batch number AHBVC200AA, expiry date 6th February 2015). Previously administered products included ENGERIX B pediatric with an associated reaction of no adverse event (1st dose). On 19th February 2015, the patient received the 4th dose of DTaP vaccine (unknown), the 2nd dose of HAVRIX 720 Junior (intramuscular) .5 ml and the 2nd dose of ENGERIX B PEDIATRIC (unknown). On an unknown date, the dose was an unknown doses. On 19th February 2015, not applicable after receiving DTPa vaccine and ENGERIX B PEDIATRIC and an unknown time after receiving HAVRIX 720 Junior, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced injection site swelling, expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the injection site swelling, inappropriate age at vaccine administration, expired vaccine used and drug dose administration interval too long were unknown. Additional information received: The patient was a 8 month-old male who received his 2nd dose of ENGERIX-B on 19 February 15, but the dose had expired on 06 February 15. First dose of Hepatitis B vaccine was given on 01 September 2014. The interval between the 1st and 2nd dose of ENGERIX-B was too long. The patient also received a DTap vaccination in the opposite thigh (right), which may or may not have been INFANRIX for 3rd or 4th dose. He had swelling on the right leg (uncertain if at injection site or more of leg) and was taken to urgent care clinic for evaluation. The patient also received HAVRIX vaccination, which was noted as 2nd dose, but that conflicts with patient's age. Reporter was not very reliable.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: This is a retrospective pregnancy case. This 39-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received the 1st dose of BOOSTRIX (other) .5 ml on 30th September 2014 10:30. The subject received BOOSTRIX at week 28 of the pregnancy and during the third trimester of pregnancy. On 30th September 2014, less than a day after receiving BOOSTRIX, the subject developed pain in arm (Non-serious). Additional event(s) included shoulder discomfort on 30th September 2014, live birth and vaccine exposure during pregnancy. The outcome of pain in arm was recovering/resolving. The outcome(s) of the additional event(s) included shoulder discomfort (recovering/resolving), live birth (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 20th December 2014 after (weeks gestation), the subject gave birth to a (gender) neonate via unknown delivery. It was unknown if the investigator considered the pain in arm, shoulder discomfort, live birth and vaccine exposure during pregnancy to be related to BOOSTRIX. Additional information: The last menstrual period, the LMP, the GA and the Apgar score were not provided. There was no issue with the baby.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date the patients received improperly stored, VAQTA (strength, dosage, route, lot# and expiration date were not reported). No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 06-SEP-2013, the patient of unknown age and gender vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is on of several reports received from the same reporter. Additional information is not expected, all available information has been received.