chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Ankyloglossia congenital, Cardiac disorder, Congenital anomaly, Echocardiogram abnormal, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case described the occurrence of tongue tie in a male infant. The 17-year-old mother was a subject enrolled in an open label study. The subject received MENVEO .5 ml on 23rd March 2012. The parent's medical history included gestational diabetes mellitus (associated with pregnancy) and sebaceous cyst (not associated with pregnancy). The mother's last menstrual period was on 13th February 2012 and estimated date of delivery was 19th November 2012. The infant was exposed to MENVEO at week 5 of gestation and during the first trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. At 40 weeks and 2 days, the infant was born via unknown delivery and weighed 3260 grams (7lbs 3oz) at birth. The infant was diagnosed with echocardiography abnormal. Additional event(s) included tongue tie (serious criteria GSK medically significant and congenital anomaly) and fetal exposure during pregnancy, first trimester. The outcome of echocardiography abnormal was unknown. The outcome(s) of the additional event(s) included tongue tie (unknown) and fetal exposure during pregnancy, first trimester (unknown). It was unknown if the investigator considered the echocardiography abnormal and tongue tie to be related to MENVEO. See case US2017GSK175493 for details regarding the mother case. Additional details were provided as follows: The parent's concomitant product exposures included folic acid, FLUARIX, Influenza vaccine, prenatal vitamins, GARDASIL, ZOFRAN ODT, BENADRYL and SUBLIMAZE. The patient's mother was not diagnosed with medical conditions or maternal complications. On 23rd March 2012, the patient's mother received a dose of MENVEO (batch number 10135). On 4th June 2012, alpha 1 foetoprotein, Human chorionic gonadotropin, unconjugated estriol and Inhibin B test showed no congenital abnormality. On 28th June 2012, abdominal ultrasound showed a congenital abnormality cardiac echogenic focus noted in left ventricle measuring 2mm. A singleton male live infant (the patient in this case) was born at gestational age of 40 weeks. The pregnancy resulted in a birth defect. The birth defect was shortened frenulum of tongue not noted prior to birth. The pregnancy did not result in fetal loss. The temporal relationship with the development of this defect and the timing of the exposure to vaccine could not be ruled out for a possible association. The etiology was unknown in most cases and could be familial. The cardiac echogenic focus was not a defect as it was not a Congenital Defects Program defect. It was unknown if the shortened frenulum of tongue was attributed to vaccination or not. Other factors that might have contributed to this outcome were unknown.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 1/2 inch warm, indurated, pink, circle at injection site of Right upper arm. Treatment=apply ice to site, BENADRYL or ibuprofen PRN/call if worsening.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pallor, Posture abnormal
Clinical narrative: Child received yearly flu vaccine in left deltoid while sitting on exam table. A few minutes later, she walked over to sit in a chair. While sitting in the chair, the pt stated, " Mom, I'm not feeling good" and was observed by this RN to turn pale and head dropped to chest. Pt's mother and this RN scooped up child and carried her over to the exam table. While lying on table, child opened her eyes and was alert. A doctor was called and vital signs taken. VSS, A+Ox3, extremities warm to touch, good radial pulses bilaterally. Child rested for 15 minutes prior to having her sit up after 5 minutes, she stood up and walked normally around the room. Provider and parent agreed child was able to leave and was escorted out to car with RN, MOC and sister.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Computerised tomogram head, Full blood count, Head injury, Loss of consciousness
Clinical narrative: Patient received his shot and then went to the checkout desk to check out. While standing at the checkout desk he passed out and hit his head on the wall.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test
Clinical narrative: Patient received his shot and then went to the checkout desk to check out. While standing at the checkout desk he passed out and hit his head on the wall.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient complained of arm pain after injection. She said she could not lay on arm that night. Patient contacted staff on 11-16-2017 and said that arm had not gotten better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: TOPICAL REACTION, RED, SLIGHTLY SWOLLEN/RAISED, WARM TO TOUCH, LIGHT RED BORDER, ABOUT THE SIZE OF 50 CENT PIECE, REPORTED 4 DAYS AFTER VACCINATION.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Oropharyngeal pain, Pain, Sneezing
Clinical narrative: Stated she received the flu shot on Wednesday and began to have symptoms on Thursday -sneezing, sore throat, body aches, and chills. Temp 98.4 today instructed to take TYLENOL, follow up with PCP.
Age: 16.0
Sex: F
Vaccine: FLU4, HEPA, MNQ
Symptoms: Asthenia, Chills, Erythema, Eyelid oedema, Fatigue
Clinical narrative: 6 PM 11/16/17: rigors chills, trouble sleeping, body weak feeling nauseous, swollen eyelids and redness this morning, feeling slightly better but still tired. Recommend BENADRYL 12 mg rest.
Age: 16.0
Sex: F
Vaccine: FLU4, HEPA, MNQ
Symptoms: Insomnia, Nausea
Clinical narrative: 6 PM 11/16/17: rigors chills, trouble sleeping, body weak feeling nauseous, swollen eyelids and redness this morning, feeling slightly better but still tired. Recommend BENADRYL 12 mg rest.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient received PNEUMOVAX 10-31-17 at approx. 10:30 AM. At approx. 2 AM she passed out in her kitchen and hit head on floor.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Cellulitis, Injection site erythema, Pain, Vaccination site swelling
Clinical narrative: Red bump right thigh at site of vaccine. Painful. Gradually increased in size. Treated as cellulitis 11-16-17 KEFLEX.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Her first time ever getting Flu shot. After 20 minutes, she was walking away from pharmacy and started stumbling. She felt really dizzy. Pharmacist called 911. Heart rate and pulse normal. She was released without going to hospital.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: Swollen armpit 12 hours later after flu vaccine. No treatment.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported severe pain, swelling and redness at the injection site that started the evening of 11/13/17 and continued until 11/15/17. No complaint during or in the 15 minutes after administration of the vaccine. Patient presented to the pharmacy on 11/15/2017 for consultation about the pain and other symptoms. The staff pharmacist evaluated the injection site and determined that mild redness and swelling was occurring. Patient reports improvement of symptoms overall since administration of the vaccine and symptoms peaked overnight on 11/13/17 and during the day on 11/14/17. Patient reports visiting her primary care physician regarding the symptoms.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Patient received multiple vaccines. Reported redness and hive like bumps at MMR and varicella injection sites. Patient given diphenhydramine 6.25 mg by mouth once following the reaction. Family sent with prescriptions for acetaminophen 80 mg by mouth every 6 hours as needed and ibuprofen 80 mg by mouth every 8 hours as needed.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Two hours after receiving the immunization, patient experienced some soreness, redness and swelling in her left arm. Shee thought that it was normal. She woke up the next morning and it was still sore, big and swollen from her shoulder to elbow and the redness was spreading under her arm to her chest. She took extra strength Tylenol which helped and also some Benadryl. She woke up today, 11/17 and the redness is still there but the itching, swelling and soreness is better.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Two hours after receiving the immunization, patient experienced some soreness, redness and swelling in her left arm. Shee thought that it was normal. She woke up the next morning and it was still sore, big and swollen from her shoulder to elbow and the redness was spreading under her arm to her chest. She took extra strength Tylenol which helped and also some Benadryl. She woke up today, 11/17 and the redness is still there but the itching, swelling and soreness is better.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient's arm started to swell up and turn red just below the injection site. The area was about 6in by 5in. Patient complained that it was warm and sore to move her arm. She spoke with her doctor who instructed her to take some BENADRYL and keep an eye on it. She came into the pharmacy 4 days after injection and it appeared that the swollen area was getting smaller and not as painful. She was picking up BENADRYL that day and was going to start it when she got home.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: The afternoon after pt received vaccines caregiver called because experienced severe nausea and chills. Patient was taken to hospital later that night and held for observation. Pt had a fever of 102.6.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury associated with device, No adverse event
Clinical narrative: This spontaneous report was received from a 31-year-old female pharmacist, who was reporting on herself. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 20-OCT-2017, the patient accidentally stuck herself with a needle that had properly stored ZOSTAVAX injection (lot # M040145 with expiration date on 26-DEC-2017; dose and route of administration were not reported). The patient did not seek a medical attention. No adverse reaction were reported.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 32 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 23-SEP-2017, the patient was vaccinated with the first dose of Human Papillomavirus GARDASIL 9 (strength, lot #, expiration date, dose, route of administration, and anatomical location were not reported), for prophylaxis. On 26-OCT-2017, the patient entered the pharmacy and requested the second dose of his GARDASIL 9 vaccination series; which was considered as an inappropriate schedule of vaccine administered. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Delivery, Exposure during pregnancy, Labour induction, Neonatal disorder, Prolonged pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a physician and refers to a 28-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included latent tuberculosis. The patient's concomitant medications included unspecified vitamins and ferrous sulfate. The patient did not have any drug reactions or allergies. On 24-APR-2017, the pregnant patient was vaccinated with a first dose of VARIVAX subcutaneously, lot# M028552 and expiration date 07-JUN-2018 (dose was not reported) for prevention of varicella. The patient's gestational age on the date of administration was 13 weeks, 1 day. The last menstrual period date was estimated on 22-JAN-2017, date of conception on 05-FEB-2017 and estimated date of delivery on 29-OCT-2017. On an unknown date in 2017, the patient had routine fetal anatomy ultrasounds, all of which were normal. The patient did not spontaneously go into labor after 40 weeks of pregnancy, so she was admitted to the medical center at 41 weeks on 06-NOV-2017 for induction of labor. On 06-NOV-2017, the patient delivered a baby with no complications. The baby was born with congenial anomaly, an "ear pit" in the right ear. The physician reported no treatment was necessary for the "ear pit." The outcome of the events was reported as resolved. The relatedness between the events and VARIVAX was not reported. The child's case was captured into MARRS# 1711USA004413. Sender's Comments:  US-009507513-1711USA004413.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: This spontaneous retrospective pregnancy report was received from a physician and refers to a 28-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included latent tuberculosis. The patient's concomitant medications included unspecified vitamins and ferrous sulfate. The patient did not have any drug reactions or allergies. On 24-APR-2017, the pregnant patient was vaccinated with a first dose of VARIVAX subcutaneously, lot# M028552 and expiration date 07-JUN-2018 (dose was not reported) for prevention of varicella. The patient's gestational age on the date of administration was 13 weeks, 1 day. The last menstrual period date was estimated on 22-JAN-2017, date of conception on 05-FEB-2017 and estimated date of delivery on 29-OCT-2017. On an unknown date in 2017, the patient had routine fetal anatomy ultrasounds, all of which were normal. The patient did not spontaneously go into labor after 40 weeks of pregnancy, so she was admitted to the medical center at 41 weeks on 06-NOV-2017 for induction of labor. On 06-NOV-2017, the patient delivered a baby with no complications. The baby was born with congenial anomaly, an "ear pit" in the right ear. The physician reported no treatment was necessary for the "ear pit." The outcome of the events was reported as resolved. The relatedness between the events and VARIVAX was not reported. The child's case was captured into MARRS# 1711USA004413. Sender's Comments:  US-009507513-1711USA004413.
Sex: U
Vaccine: VARCEL
Symptoms: Congenital anomaly, Delivery, Foetal exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a physician and refers to a newborn patient of unknown gender. The patient's concurrent conditions and concomitant therapies were not reported. On 24-APR-2017, the patient's mother was vaccinated with a dose of VARIVAX subcunateously, lot# M028552 and expiration date 07-JUN-2018 (dose was not reported) for prevention of varicella when she was pregnant. Her gestational age on the date of administration was 13 weeks, 1 day (second trimester), last menstrual period date was estimated on 22-JAN-2017. On an unknown date in 2017, the patient's mother had routine fetal anatomy ultrasounds, all of which were normal. On 06-NOV-2017, at 41 weeks of pregnancy, the patient was born with no complications. It was noted upon delivery that the patient was born with congenital anomaly, an "ear pit" in the right ear. Physician reported that no treatment was necessary for the "ear pit". The outcome of the event was unknown. The relatedness between the event and VARIVAX was not reported. Upon internal review, the "ear pit" was considered to be medically significant event. The mother's case was captured in MARRS# 1711USA004407.; Sender's Comments: US-009507513-1711USA004407:
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This report was received via a Pfizer sales representative. A female patient of an unspecified age (age: 82, unit: unspecified) and ethnicity received PREVNAR 13, intramuscular in the left deltoid on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe redness, swelling, fever, body aches on an unspecified date. The patient ended up in ER. Outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and 24 hours later, became unbelievably sick on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Anal incontinence, Diarrhoea, Dizziness, Feeling cold, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for herself). A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration on 07Nov2017 at single dose for pneumonia vaccine at Physician office. Medical history included depression and reflux. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) for depression and esomeprazole magnesium (NEXIUM) for reflux; both ongoing. Patient also reported she was taking vitamins. The patient previously took amoxicillin and experienced diarrhoea, hives, liver enzymes and potassium went off the charts and lost 25 pounds. It was also reported that the patient had a pneumonia vaccine prior but she does not think it was pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) because she did not have any reaction to it. It was reported that the night of 07Nov2017, patient woke up in the middle of the night with a violent headache. The patient could not sleep as the headache was so bad. Patient stated that her headache was much milder than it was. Patient also reported experiencing diarrhea. Patient was not sure when the diarrhea started but it has been constant. Patient informed that she read the side effect on the website. Patient also reported that she felt faint and vomited once in the middle of night on Wednesday, 08Nov2017. The patient reported that she cannot stand up or she will leak all over herself. Stated that she cannot even sit up and reported that there was not stool but it was a yellow liquid that looks like a bile. Patient also reported experiencing fever after the shot. It was reported that highest temperature was 102 yesterday (as reported). Patient stated that her fever usually stays around 100.3 or 100.4. Patient also reported that she thought diarrhea started when the fever may have started which she thought was on Wednesday (as reported) and that her fever was 100.3 then. Patient thought that something was really wrong since she could not get warm. The patient reported that she was healthy. Outcome of the events headache, fever, and diarrhea was not recovered, while felt faint and vomited was recovered on unspecified date in Nov2017 and outcome of other events was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Sleep disorder, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for herself). A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration on 07Nov2017 at single dose for pneumonia vaccine at Physician office. Medical history included depression and reflux. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) for depression and esomeprazole magnesium (NEXIUM) for reflux; both ongoing. Patient also reported she was taking vitamins. The patient previously took amoxicillin and experienced diarrhoea, hives, liver enzymes and potassium went off the charts and lost 25 pounds. It was also reported that the patient had a pneumonia vaccine prior but she does not think it was pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) because she did not have any reaction to it. It was reported that the night of 07Nov2017, patient woke up in the middle of the night with a violent headache. The patient could not sleep as the headache was so bad. Patient stated that her headache was much milder than it was. Patient also reported experiencing diarrhea. Patient was not sure when the diarrhea started but it has been constant. Patient informed that she read the side effect on the website. Patient also reported that she felt faint and vomited once in the middle of night on Wednesday, 08Nov2017. The patient reported that she cannot stand up or she will leak all over herself. Stated that she cannot even sit up and reported that there was not stool but it was a yellow liquid that looks like a bile. Patient also reported experiencing fever after the shot. It was reported that highest temperature was 102 yesterday (as reported). Patient stated that her fever usually stays around 100.3 or 100.4. Patient also reported that she thought diarrhea started when the fever may have started which she thought was on Wednesday (as reported) and that her fever was 100.3 then. Patient thought that something was really wrong since she could not get warm. The patient reported that she was healthy. Outcome of the events headache, fever, and diarrhea was not recovered, while felt faint and vomited was recovered on unspecified date in Nov2017 and outcome of other events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 1st of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a red blotchy rash in the area surrounding the injection site, not directly at the injection site. This rash lasted approximately 7 days and resolved on its own. There was no itching or pain associated with the rash. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017492902 same reporter/drug/event, different patient; US-PFIZER INC-2017492903 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a red blotchy rash in the area surrounding the injection site, not directly at the injection site. This rash lasted approximately 7 days and resolved on its own. There was no itching or pain associated with the rash. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017492889 same reporter/drug/event, different patient; US-PFIZER INC-2017492903 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a red blotchy rash in the area surrounding the injection site, not directly at the injection site. This rash lasted approximately 7 days and resolved on its own. There was no itching or pain associated with the rash. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017492902 same reporter/drug/event, different patient;US-PFIZER INC-2017492889 same reporter/drug/event, different patient
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A female patient (Age: 65, Units: Unknown) of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included influenza vaccine administered on the same day in the same arm for immunization. The patient experienced arm stiffness on an unspecified date after use of the product. The outcome of the event was unknown.
Sex: M
Vaccine: FLU4, MENB
Symptoms: Chills, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a 16-year-old male patient who received BEXSERO (batch number 169821, expiry date unknown). Concomitant products included FLUZONE. On 6th November 2017, the patient received BEXERO (intramuscular) .5 ml. On 7th November 2017, 1 days after receiving BEXSERO, the patient experienced vomiting and chills. On an unknown date, the outcome of the vomiting and chills were unknown. The reporter considered the vomiting and chills to be unlikely related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO on right arm and FLUZONE on left arm. The patient experienced vomiting and chills approximately 24 hours after vaccination with BEXSERO and FLUZONE. The patient's physician did not thaught that this was related to BEXSERO. No follow-up visit was required.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Sleep disorder
Clinical narrative: I received Flu shot in my left upper arm; I woke up in the morning with shoulder pain and limited range of motion. I called pharmacy several times with my complaint and they said someone would call me back but it took 2 weeks before someone responded to my concerns and advised me to see my doctor. I went to my general practitioner on 10/27/17 and he advised me to see an orthopedic doctor. I have had pain and limited range of motion for 8 weeks now and the pain in more intense when lying down preventing me from getting much sleep; I also have difficulty with upper body dressing and require assistance due to lack of range of motion and severe pain. I am scheduled to see orthopedic doctor for further treatment.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient returned to the pharmacy stating that she had had continuing arm pain several days after the vaccine on 10/13/17 and continues to have pain. She has seen her physician and has started physical therapy.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia, Sleep disorder
Clinical narrative: Patient reported to the Clinic on 11/16/2017 at 18:00 with complaint of Left shoulder pain and fever. The patient had an influenza vaccine and an pneumonia vaccine given yesterday in the left upper deltoid. Six to seven hours later she was experiencing significant pain in the shoulder and difficulty moving the shoulder due to pain. She also had experienced a fever of 102. She was not able to sleep laying down last night because that exacerbated the pain so she tried to sleep sitting up. Fever persists through today and now has been present for greater than 24 hours. She has been holding her arm in a sling for comfort and using ibuprofen. She is rating her pain at rest at a 2/10 and with movement 6/10 to 7/10. Plan: 1. Imaging of the left shoulder by MRI scheduled for 11/17/2017. 2. Patient was given 1.2 million units BICILLIN LA intramuscularly 11/16/2017 at 19:00. 3. Advised to seek Emergent care at the Emergency Department if worsens overnight. 4. For pain management she will use oxycodone 5 mg every four hours as needed for pain. 5. Proceed to MRI left shoulder tomorrow. If this exam is not available as an outpatient I have recommended that the patient present to the Emergency Department for further evaluation.
Age: 91.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 18 hours post administration: Redness, swelling, warmth upper arm around vaccine injection site between shoulders and elbow.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain in deltoid area starting approx 4 days later gradually extending down to elbow and also involving (L) shoulder. Very limited mobility in (L) arm for 6 weeks. Still have some pain in arm. There was never any redness or edema, only pain.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Hard spot, red circle, slight warmth to touch, no fever, child acting like herself.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt stated soreness and pain RUE started around 10 P.M on 9-21-17. Decreased ROM continued with pain saw Dr. instructed to do ROM and warm moist compress continuous to do as Dr. prescribed and ROM is returning still has some pain and soreness but is less.
Age: 67.0
Sex: M
Vaccine: YF
Symptoms: Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: Email 11-17-17 patient wrote: "On Nov. 8 I visited your clinic and received a yellow fever vaccination. I had not side effects until Nov. 12, when I felt very lethargic and later found that I had a fever. On Nov. 12 and 13, by body temperature ranged from 101F to 102.5F. On Nov. 13, my temperature was close to normal. However, on Nov. 14 and even today, I am experiencing a low grade fever ranging from 99F to 100F. I am assuming that this is a side effect of the vaccination and have thus not been alarmed. Should I be? If this is related to the vaccine, how long should I expect it to persist? I don't seem to have any other symptoms; just the not-quite-normal feeling that comes from having an abnormal temperature. I would appreciate your comments." I spoke with patient who verified above. He stated that he did not feel sick just the low grade fever. I encouraged him to go to the emergency room and to contact his doctor immediately. Dr. aware. STAMARIL AE and VAERS report sent.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None noted.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Dyskinesia, Scratch
Clinical narrative: Scratch on arm due to jerking and incomplete penetration.
Age: 9.0
Sex: F
Vaccine: MMRV
Symptoms: Fatigue, Injection site rash, Injection site scab, Injection site swelling, Peripheral swelling
Clinical narrative: Major arm swelling, site enlarging every few hours, scabby injection site, rash all over entire right arm and right side of body spreading to abdomen, armpit, chest, lower belly, tiredness, mild fever.
Age: 9.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Major arm swelling, site enlarging every few hours, scabby injection site, rash all over entire right arm and right side of body spreading to abdomen, armpit, chest, lower belly, tiredness, mild fever.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Eye movement disorder, Hypothermia
Clinical narrative: Patient went to ED for possible seizure. He had an episode of hypothermia, cyanosis and abnormal eye movements...possible first time seizure. ED recommended outpatient Neuro. f/u. Appt. for EEG and referral sent to Neuro.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Immune thrombocytopenic purpura, Increased tendency to bruise, Menorrhagia
Clinical narrative: Idiopathic Thromocytopenia..... first signs: longer periods, excessive bruising.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Prolonged shoulder/arm pain 17 days after injection of FLUZONE Lot # U1815AB into right deltoid on 10/23/2017. Mild restriction to range of motion with this pain.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Eye oedema, Face oedema
Clinical narrative: 20 minutes after receiving vaccine, employee experienced facial/eye edema, feelings of shortness of breath, chest redness. Treated in ER with EPI PEN, steroids, BENADRYL.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm red and swollen. Hot to touch.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, HIBV, MMRV, PPV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a 12 month old male patient. No information regarding medical history, concurrent conditions and concomitant therapies was provided. On 18-OCT-2017, the patient was inadvertently vaccinated with VARIVAX lot # N012487 with expiration date on 20-APR-2019 (dose and route were unspecified) for prophylaxis and PROQUAD lot # N013268 with expiration date on 25-OCT-2018 (dose and route were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Decreased appetite, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old female patient. The patient's concurrent conditions included diabetes. The patient had no drug/reactions allergies. The patient's concomitant medications included metformin and simvastatin (manufacturer unknown). The patient's historical drugs included PREVNAR 13 received on 07-NOV-2016. On 24-OCT-2017 at "about 13:00", the patient was vaccinated with a booster dose of PNEUMOVAX 23 1 shot , in the right arm, lot # N013541 with expiration date 23-JAN-2019, for prophylaxis (route of administration was not reported). On the same date, the patient also was vaccinated with a dose of influenza virus vaccine (unspecified), 1 shot, in the left arm, for prophylaxis (route of administration, lot # and expiration date were not provided). It was reported that later that day, the patient experienced swelling, redness that was hot to the touch, pain "that went about three quarter of the way around her right arm", below the injection site "in the forearm area". Additionally, the patient experienced chills, low grade fever and loss of appetite. No treatment was given for the adverse events. At the time of reporting the outcome of the events was reported as recovering (also reported as " feeling fine"). The causality assessment between peripheral swelling, erythema, feeling hot, and pain in extremity with the suspect therapies was not provided. The reporting pharmacist considered chills, pyrexia, and decreased appetite to be related to influenza virus vaccine (unspecified). It was also reported that the pharmacist gave nine shots of PNEUMOVAX 23 out of the box on the same date, but this patient was the only one with a reaction.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old female patient. The patient's concurrent conditions included diabetes. The patient had no drug/reactions allergies. The patient's concomitant medications included metformin and simvastatin (manufacturer unknown). The patient's historical drugs included PREVNAR 13 received on 07-NOV-2016. On 24-OCT-2017 at "about 13:00", the patient was vaccinated with a booster dose of PNEUMOVAX 23 1 shot , in the right arm, lot # N013541 with expiration date 23-JAN-2019, for prophylaxis (route of administration was not reported). On the same date, the patient also was vaccinated with a dose of influenza virus vaccine (unspecified), 1 shot, in the left arm, for prophylaxis (route of administration, lot # and expiration date were not provided). It was reported that later that day, the patient experienced swelling, redness that was hot to the touch, pain "that went about three quarter of the way around her right arm", below the injection site "in the forearm area". Additionally, the patient experienced chills, low grade fever and loss of appetite. No treatment was given for the adverse events. At the time of reporting the outcome of the events was reported as recovering (also reported as " feeling fine"). The causality assessment between peripheral swelling, erythema, feeling hot, and pain in extremity with the suspect therapies was not provided. The reporting pharmacist considered chills, pyrexia, and decreased appetite to be related to influenza virus vaccine (unspecified). It was also reported that the pharmacist gave nine shots of PNEUMOVAX 23 out of the box on the same date, but this patient was the only one with a reaction.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 66 year old male patient. Medical history and concurrent conditions were not provided. On 10-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscularly (lot# and the expiration date were not reported) for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) high dose. Concomitant therapies included insulin glargine (LANTUS) and other unspecified medications. On the same date and within 24 hours, the patient experienced unspecified side effects (adverse event). The patient was seen by pharmacist, but did not receive any treatment for the event.   At the time of reporting, the outcome of adverse event was reported as not recovered. The relatedness between the therapy with PNEUMOVAX 23 and the adverse event was not reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. On an unspecified date (reported as when the patient was a little kid), the patient got a series of VARIVAX subcutaneous injection (dose, lot# and expiration date were not reported) and a series of M-M-R II subcutaneous injection (dose, lot# and expiration date were not reported). On an unspecified date, the reporter stated that the patient showed absolutely no titers for either vaccine. In approximately October (reported as about a month ago), the patient received a 1 dose of VARIVAX and 1 dose of M-M-R II. On 30-OCT-2017 (reported as this past Monday), the patient received a second dose of VARIVAX. The outcome of the adverse events was not reported. Causality assessment was not provided.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site swelling, Respiratory symptom
Clinical narrative: Swelling in upper left arm x2d. This 5 year 4 month old male presents with 3 days of upper respiratory symptoms. Swelling in upper left arm x 2 days. Left deltoid measurement is 9 3/4 inch.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Diarrhea, headache, nausea w/out vomiting, joint pain, dizziness, fever, chills, pain at injection site.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Diarrhea, headache, nausea w/out vomiting, joint pain, dizziness, fever, chills, pain at injection site.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer: Contacting patients for re-vaccination.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patient for re-vaccination.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 1.42
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 1.25
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.75
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Musculoskeletal disorder
Clinical narrative: Injection site, hard and red. Patient unable to use arm.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Myalgia, Vomiting
Clinical narrative: Pt notes w/in 2 hours of received PPV23 vaccine pt developed uncontrolled vomiting then diarrhea muscle aches.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen, at site of injection.
Age: 4.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Muscular weakness, Pallor
Clinical narrative: Had flu vaccine and then started to walk out into hallway. Knees gave way fell to floor. Kept in clinic x 25 min. No head injury. Color improved. Called Dr. made aware of above, has scheduled with nurse at 1500 today.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, nausea, diarrhea, stomach pain, fatigue, vomit.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Fever, nausea, diarrhea, stomach pain, fatigue, vomit.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, warmth, pain at injection site. Headache w/minor chills. BENADRYL and TYLENOL.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, warmth, pain at injection site. Headache w/minor chills. BENADRYL and TYLENOL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Large local reaction - swelling/redness at injection site. Started within 24 hours of immunization. Reaction at site of MMR/V injection, not DTap/IPV. Supportive care (BENADRYL, ibuprofen, cool compresses) recommended.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 1.17
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 1.42
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacture. Contacting patient for re-vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient stated that her arm was very sore and around 5 pm the night she received the vaccine her arm swelled and turned red through the entire upper left arm. Patient went to the primary care doctor and was treated with generic KEFLEX.