chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS, FLU3
Symptoms: Pain, Somnolence
Clinical narrative: After I got the flu shot I had a very sore upper arm where I got the shot. Otherwise I felt ok. The next day I felt weak, tired and ached. No energy. That night I had severe pain in my neck and head. Pain that did not respond to ibuprofen at all. That Friday, Sat. and Sunday I felt like I had the flu. No appetite. All I wanted to do was sleep. At nite my neck pain was severe! I couldn't rest my head in any direction and feel comfortable. I was miserable!! Monday morning my husband took me to the Urgent Care. I was seen by Dr. He said I had very swollen lymph glands in my neck under my ears and along the base of the skull. He prescribed amoxicillin 500 mg 3x a day for 10 days. Which I have completed. Today Sept. 28, 2017 I still have slight soreness in my neck and I am still tired all the time. I feel I am slowly getting better but it sure took a long time for me to start to get well. If I had known I was getting a high dose flu shot I would have probably refused it. I have taken regular flu shots for many years and never had a reaction from them. I am afraid of taking another flu shot again. I'll discuss it with my Dr. next year. I hope no one gets a reaction like I did.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Fatigue, Impaired work ability, Malaise, Pain
Clinical narrative: 9:30, AM fever/chills, sore throat. 10:50 AM, muscle aches, fatigue. 11 AM, cough, headache. 11 AM, runny/stuffy nose. 1 PM, nausea, mild diarrhea. Symptoms continued for a full week, but became less each day.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pyrexia
Clinical narrative: 9:30, AM fever/chills, sore throat. 10:50 AM, muscle aches, fatigue. 11 AM, cough, headache. 11 AM, runny/stuffy nose. 1 PM, nausea, mild diarrhea. Symptoms continued for a full week, but became less each day.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: 9:30, AM fever/chills, sore throat. 10:50 AM, muscle aches, fatigue. 11 AM, cough, headache. 11 AM, runny/stuffy nose. 1 PM, nausea, mild diarrhea. Symptoms continued for a full week, but became less each day.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Nasal congestion, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: 9:30, AM fever/chills, sore throat. 10:50 AM, muscle aches, fatigue. 11 AM, cough, headache. 11 AM, runny/stuffy nose. 1 PM, nausea, mild diarrhea. Symptoms continued for a full week, but became less each day.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rhinorrhoea
Clinical narrative: 9:30, AM fever/chills, sore throat. 10:50 AM, muscle aches, fatigue. 11 AM, cough, headache. 11 AM, runny/stuffy nose. 1 PM, nausea, mild diarrhea. Symptoms continued for a full week, but became less each day.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a physician via Rocky Mountain poison and drug center, referring to another female physician of unknown age. Her medical history was unknown. Her concomitant medication included omeprazole for the treatment of gastrooesophageal reflux disease (GERD). On 22-SEP-2017 at 16:30, the patient was vaccinated with ZOSTAVAX (once, route reported as injected and dose not reported) for prophylaxis. She did not had the lot number or expiration date but said her doctor's office would have that information available. Almost immediately after injection, she developed an injection site rash which had progressively got worsen each day. She had no relevant labs. As of 24-SEP-2017, she no longer used ZOSTAVAX and the outcome of her injection site rash was unknown. Causality assessment was not provided by the reporter. The safety report US-009507513-1709USA012400 has been submitted with an incorrect aware date of 25-SEP-2017, the report will be nullified and the information with the correct aware of 24-SEP-2017 will be submitted in this new safety report US-009507513-1710USA001090. This is an amended report, as corrected. The aware date was changed from 25-SEP-2017 to 24-SEP-2017.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Rash
Clinical narrative: PATIENT DEVELOPED A RASH ON THE RIGHT LOWER SIDE OF FACE. DESCRIBED AS TINGLING AND BURNING SENSATION. ADVISED HIM TO SEE DR AND THEY PRESCRIBED HIM ACYCLOVIR 800 MG QID FOR 7 DAYS
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Arrhythmia, Blood test normal, Chest X-ray normal, Dizziness, Electrocardiogram normal
Clinical narrative: Palpitations and arrhythmia, while sleeping, light headedness, nausea, noon mid day 10/3/2017. walked to hospital for .6 miles while at hospital was resolved.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Nausea, Palpitations
Clinical narrative: Palpitations and arrhythmia, while sleeping, light headedness, nausea, noon mid day 10/3/2017. walked to hospital for .6 miles while at hospital was resolved.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Blood test, Dehydration, Nausea, Oesophagogastroduodenoscopy normal
Clinical narrative: After receiving vaccine at 4:44pm by 6:15pm my stomach was in so much pain I was doubled over and with in 10 min I was vomiting every 10-15 min could not even keep water down after the second day straight of vomiting I went to urgent care where I recived iv fluids from being dehydrated given Zofran for the nausea and was told to go straight to the emergency room where I went to hospital and was given more fluid and Zofran was told to have an egd done to make sure this was a reaction to the flu vaccine and not something else I had the procedure and nothing else was found.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Urine analysis, Vomiting
Clinical narrative: After receiving vaccine at 4:44pm by 6:15pm my stomach was in so much pain I was doubled over and with in 10 min I was vomiting every 10-15 min could not even keep water down after the second day straight of vomiting I went to urgent care where I recived iv fluids from being dehydrated given Zofran for the nausea and was told to go straight to the emergency room where I went to hospital and was given more fluid and Zofran was told to have an egd done to make sure this was a reaction to the flu vaccine and not something else I had the procedure and nothing else was found.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Skin warm, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 52-year-old female patient with hypothyroidism (reported as "hypothyroid") and penicillin allergy. On 08-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX, injection, subcutaneous, (dose, dose number, injection site, lot number and expiration date were not provided) for the prevention of shingles. There were no concomitant medications reported. The reporter stated that the patient's "sub-cu tissue became red, hot, swollen and painful to the touch" after receiving ZOSTAVAX (on 08-SEP-2017). It was also reported that the patient experienced lymphadenopathy which lasted until the next day. According to the reporting medical assistant, the patient saw a nurse practitioner as a precaution, however, no treatment was given for the adverse events. The outcome of erythema, pain of skin, skin swelling and skin warm was unknown. The relatedness between the adverse events and suspect therapy was not provided. Additional information is not expected as no permission has been granted to contact the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a pharmacy intern and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-AUG-2017 (reported as "2-3 weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, route of administration, lot# and expiration date were not provided) for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date in 2017, the patient experienced elbow joint pain. The patient has not gone to a physician yet and has not taken any medicine for the event. The reporter additionally asked, if the patient could receive a flu vaccine. The outcome of the event and the causal relationship between the event and ZOSTAVAX was not provided.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2014, the patient was vaccinated with PNEUMOVAX 23 subcutaneously, lot # J006082, expiration date 12-APR-2014 (dose was not reported). On an unknown date, the patient experienced "a severe allergic reaction" and injection site arm swelled and became bright red. The patient visited a physician office the next day, but no treatment was given. There were no lab diagnostic studies performed. No product quality complaint has been filled. The outcome of the events was reported as recovered/resolved (reported as swelling and redness went away in about 2 or 3 days). The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's historical drugs, medical history concomitant therapies and concurrent conditions were not reported. On 25-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL lot # L043213 and expiration date 28-AUG-2017 for prophylaxis. Strength, dose, route and frequency were not provided. No adverse effects were reported and there was no product quality complaint involved.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician and refers to a currently age 34, not pregnant,  female patient. The patient had an antecedent of allergies to penicillin and unspecified sulfa drugs. Concomitant therapies and concurrent conditions were not reported. On an unspecified date, at age of 12 year old, the patient was vaccinated with a dose of VARIVAX for prevention of varicella, reconstituted with sterile diluent (MERCK STERILE DILUENT). The number of doses and dates of vaccination were unknown (Strength, dose, route, frequency, lot # and expiration date were not reported). On an unspecified date in 2016, reported as "within the past year",  the patient had negative titers for varicella (antibody test negative). The patient did not receive treatment. The outcome of antibody test negative was unknown and the assessment causality between VARIVAX with the event mentioned before was not provided. There was no product quality complaint involved.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 month old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-SEP-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L035674 and expiration date on 17-SEP-2017, subcutaneously (dose was not reported) for prophylaxis, which was reconstituted with sterile diluent (DILUENT MRK). No adverse effects were present. There were no temperature excursions and no product quality complaints reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test normal, Splenomegaly, Tenderness, Ultrasound scan normal
Clinical narrative: This spontaneous report as received from a physician via a Company representative referring to a 12 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. On 11-AUG-2017, the patient came into the physician's office for a routine wellness and it was found that on examination the patient had an enlarged spleen of approximately 3 cm. Then, on 18-AUG-2017, the patient returned to the office for a follow up visit and it was found that her spleen was still enlarged by about 2 cm. After that, the patient came into the physician's office for another follow up on an unspecified date in 2017, and it was found that the spleen tip seemed swollen and tender. On an unspecified date in 2017, the patient was sent for laboratory diagnostics (unspecified) and ultrasound and it was found that those came back to normal. The physician reported that the patient was recovered but still experiencing some tenderness around the spleen, therefore, it was recommended limited activity until the tenderness subsided. It was also mentioned that the patient received unspecified treatment for splenomegaly. It was reported that no intervention to prevent serious criteria was necessary, that splenomegaly was not significant disability or incapacity or life threatening, and that the patient was not hospitalized. No product quality complaint was involved. The relatedness assessment between GARDASIL 9 and splenomegaly was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Eyelid function disorder, Facial pain, Gait disturbance, Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-OCT-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Approximately December 2015 (reported as two months after receiving ZOSTAVAX), the patient developed a severe, persistent pain in her face. The patient presented to the emergency room and was diagnosed with trigeminal neuralgia, a condition of chronic, sharp, shock-like pain which affects the trigeminal nerve secondary to a shingles infection. The patient continues to suffer sharp shooting pain, hearing loss, difficulty opening her eyes and walking. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages  and  required  extensive  medical  care  and  treatment.  As  a further  proximate  result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, hearing loss was considered medically significant event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Trigeminal neuralgia
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-OCT-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Approximately December 2015 (reported as two months after receiving ZOSTAVAX), the patient developed a severe, persistent pain in her face. The patient presented to the emergency room and was diagnosed with trigeminal neuralgia, a condition of chronic, sharp, shock-like pain which affects the trigeminal nerve secondary to a shingles infection. The patient continues to suffer sharp shooting pain, hearing loss, difficulty opening her eyes and walking. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages  and  required  extensive  medical  care  and  treatment.  As  a further  proximate  result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, hearing loss was considered medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Anaphylactic reaction, Flushing, Rhinorrhoea, Wheezing
Clinical narrative: Initial unsolicited report received from physician on 18-SEP-2017 and additional information also received on 18-Sep-2017. This case involves a four-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE (frequency once, batch number: U4698CB, expiration date: 30 Jun 2014, dose and site of administration was not reported) via intramuscular route on 25-Sep-2013. The patient's medical history and concomitant medications were not reported. On an unknown day, within 15 minutes following the vaccination, the patient experienced flushing, severe abdominal pain, wheezing, copious amount of nasal drainage. On an unspecified date, post vaccination, the patient experienced anaphylaxis due to gelatin content. Lab data was not reported. The patient received corrective treatment with epinephrine and given prednisone. On an unknown date, the patient recovered from events while patient was at office and patient was able to return home. This case was considered as serious due to medically significant events. List of documents held by sender: none. Sender's Comments: Patient experience anaphylaxis to INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE due to gelatin content. Time to onset is compatible. Anaphylaxis can cause by medication, insect bite, any exposure to chemical and also Information such as patient medical history, concomitant medication, and adverse reactions to previous vaccinations, is needed to further assess this case. Based on available information role of vaccine cannot be excluded.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Eye swelling, Fatigue, Injection site pain, Poor quality sleep
Clinical narrative: Fatigue, soreness at the site, and wheezing within hours. 14 hours after (during the night), development of hives across upper buttocks, up the back, on both sides of torso, up the abdominal region mostly on left side, and onto left breast area. Woke up with hoarseness. Itchy. Left eye is a bit swollen. Feeling fatigued, not rested or refreshed.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria, Wheezing
Clinical narrative: Fatigue, soreness at the site, and wheezing within hours. 14 hours after (during the night), development of hives across upper buttocks, up the back, on both sides of torso, up the abdominal region mostly on left side, and onto left breast area. Woke up with hoarseness. Itchy. Left eye is a bit swollen. Feeling fatigued, not rested or refreshed.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Full blood count normal, Influenza virus test negative, Malaise, Metabolic function test normal
Clinical narrative: Pt reports he became "violently ill Thursday evening after receiving Flu shot Thursday afternoon..." including: cough, runny nose, feeling crappy, generalized body aches and pains.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Rhinorrhoea, Urine analysis normal
Clinical narrative: Pt reports he became "violently ill Thursday evening after receiving Flu shot Thursday afternoon..." including: cough, runny nose, feeling crappy, generalized body aches and pains.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Employee reports she began having pain at the injection site approximately one hour after the vaccine was administered. She stated that the pain continued through out the day (pain is described as soreness), and into the night. She further stated that the pain woke her up twice during the night, and upon waking up this morning she noticed that the injection site area was red and swollen.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm soreness that has persisted.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Dyspnoea, Erythema, Nausea, Pyrexia, Swelling
Clinical narrative: Child received IPV and KINRIX on same day. No treatment at this time. Parent educated to monitor for adverse reaction including: fever, swelling, redness, nausea, vomiting, difficulty breathing. Informed parent to call or return to office with any concerns.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Child received IPV and KINRIX on same day. No treatment at this time. Parent educated to monitor for adverse reaction including: fever, swelling, redness, nausea, vomiting, difficulty breathing. Informed parent to call or return to office with any concerns.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Shingles on right shoulder and right arm to elbow; evaluated by family doctor and diagnosis of shingles confirmed; patient treated with antiviral medication.
Age: 8.0
Sex: F
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Imms. given at 5:20 PM. Remained in clinic to observe. At 5:25 PM Mom noted redness to Right thigh at injection sites. Examined and found redness and hives covering right upper thigh at injection sites. No other rashes/hives/redness located to entire rest of body. Observed in office. Placed cool cloth and ice to leg. Patient C/O itching to site. Denies any other signs or symptoms. Observed until 6:10 PM when Mom chose to take her home to observe. Declined to take to ER or other medical facility. No PCP. Called this AM and hives remain but no worse. Mom has given 2 doses of BENADRYL. Will continue to monitor and call for changes. To get medical treatment right away for issues.
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure increased, Chills, Cold sweat, Headache, Nausea
Clinical narrative: Patient waited 15 min after vaccine administration with no signs or symptoms. Patient was cleared and left clinic. Patient returned to clinic 15 min after leaving with complaints of headache, nausea, chills, cold sweats. Patient also had an elevated blood pressure of 147/87. Patient was transported to hospital via EMS at 0910.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Increasing shoulder pain starting a few hours after the injection and increasing through the night progressing to the point that I have severe difficulty lifting my arm over my head. have been treating with ice and ibuprofen.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Pt reports headache, pain at site of vaccine, chills, muscle/body aches. Started a few hours after the vaccine, reports she was finally able to fall asleep, she called us to report shortly after waking up, cannot tell yet if it is any less severe than yesterday.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: At 1645 on 10/02/17, patient started having a persistent cough accompanied by a feeling of a "hard time breathing". Within fifteen minutes the cough had increased in frequency and severity to where she felt congested even, At that time she developed pain in the back of her neck accompanied by a headache and dizziness. Denies facial or oral swelling. Contemplated on going to the hospital. Instead she took 50 mg. of Benadryl by mouth. At 1830 she also took 800 mg. Motrin by mouth. At 1845 she felt warm. She checked her temperature- it was 102 F. She took a warm bath as she felt chilled. She did not really feel better with the congested feeling and difficulty breathing until around midnight. Her temperature at that time was down to 101.3 F.She admits to being afraid to lie down- slept at intervals sitting up.  Finally at 0300 of 10/03 she felt better with her breathing and her temperature was decreased to 99 F. She denies having to seek further treatment or medications since.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Neck pain, Respiratory tract congestion, Skin warm
Clinical narrative: At 1645 on 10/02/17, patient started having a persistent cough accompanied by a feeling of a "hard time breathing". Within fifteen minutes the cough had increased in frequency and severity to where she felt congested even, At that time she developed pain in the back of her neck accompanied by a headache and dizziness. Denies facial or oral swelling. Contemplated on going to the hospital. Instead she took 50 mg. of Benadryl by mouth. At 1830 she also took 800 mg. Motrin by mouth. At 1845 she felt warm. She checked her temperature- it was 102 F. She took a warm bath as she felt chilled. She did not really feel better with the congested feeling and difficulty breathing until around midnight. Her temperature at that time was down to 101.3 F.She admits to being afraid to lie down- slept at intervals sitting up.  Finally at 0300 of 10/03 she felt better with her breathing and her temperature was decreased to 99 F. She denies having to seek further treatment or medications since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUX, MMRV
Symptoms: Gait inability
Clinical narrative: Inability/ refusal to walk x 12 hours that resolved. No swelling, induration/ erythema, no fevers or chills or other systemic symptoms.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor, Urticaria
Clinical narrative: This spontaneous report as received from a nurse, referring to a female patient of unknown age. The patient had was allergic to ciprofloxacin. The patient's medical history and concomitant therapies were not reported. On 21-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N019348, expiration date 08-FEB-2019, intramuscular, for prevention of pneumonia (strength, dose and frequency were not reported). Later on the same date, the patient experienced pain in arm that vaccine was administered in that was shooting into fingers (pain in extremity), fever, shaking, and hives, so the patient began taking cephalexin (KEFLEX) 500 mg twice daily for 7 days. The patient sought medical attention by calling physician medical practice and informed that her symptoms were much improved. No laboratory diagnostic studies and no intervention to prevent serious criteria were performed. The assessment causality between pain in extremity, hives, fever and shaking with PNEUMOVAX 23 was not reported.; Sender's Comments: US-009507513-1710USA000621: US-009507513-1710USA000626:
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor, Urticaria
Clinical narrative: This spontaneous report as received from  a nurse, referring to a female patient of unknown age. The patient's historical drugs, medical history,concomitant therapies and concurrent conditions were not reported. On 14-SEP-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N019348 and expiration date 08-feb-2019, intramuscular, for prevention of pneumonia (strength, dose and frequency were not reported). Late, on the same date, the patient experienced  pain in arm  that vaccine was administered in that was shooting into fingers (pain in extremity), fever, shaking, and hives", so the patient began to applying ice to the affected area. The patient sought medical attention by calling nurse, but no intervention to prevent serious criteria was performed. The outcome of pain in extremity, fever, shaking, and hives were reported as recovered/resolved in September 2017 (also reported as recovery date unspecified; conflicting information). The assessment causality between pain in extremity,fever, shaking, and hives with PNEUMOVAX 23 was not reported.; Sender's Comments:  US-009507513-1710USA000626: US-009507513-1709USA015022:
Sex: U
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of passed out in a 64-year-old patient who received Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient passed out after receiving flu shots.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Mobility decreased
Clinical narrative: Had flu shot at 3 PM - worked till 7:30 PM. Went to a 2 hour dance class then home and to bed. At 3 AM - woke up with a headache and unable to move arms or legs. Admitted to hospital.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Autopsy, Death, Sudden infant death syndrome
Clinical narrative: Patient passed away on 9/2/17. Cause was apparent SIDS but autopsy results are still pending.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Pt never did have an adverse reaction.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: Arm was red from shoulder to elbow. Was seen by physician on 09/28/17.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, soreness, warmth on injection site, and swelling.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Mom called the day following vaccine administration to say pt's left upper arm ("the arm in which she received 2 shots") initially was sore right after the vaccines, then later that night was noted to be itchy (mom discouraged pt from itching the area). Mom says the following morning the left upper arm had 2 red, swollen lumps in the areas where the vaccines were administered; mom reports the swelling was "about the size of a quarter". Afebrile, otherwise feeling well, affect per usual.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site swelling
Clinical narrative: Mom called the day following vaccine administration to say pt's left upper arm ("the arm in which she received 2 shots") initially was sore right after the vaccines, then later that night was noted to be itchy (mom discouraged pt from itching the area). Mom says the following morning the left upper arm had 2 red, swollen lumps in the areas where the vaccines were administered; mom reports the swelling was "about the size of a quarter". Afebrile, otherwise feeling well, affect per usual.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Bradycardia, Differential white blood cell count, Feeding tube user, Full blood count
Clinical narrative: Apnea, bradycardia, desaturations starting 9/30/17 0030. Infant required stimulation, oxygen and tube feeds. Infant was monitored, feeds advanced. Weekly labs were drawn on 10/2/17.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Laboratory test, Oxygen saturation decreased
Clinical narrative: Apnea, bradycardia, desaturations starting 9/30/17 0030. Infant required stimulation, oxygen and tube feeds. Infant was monitored, feeds advanced. Weekly labs were drawn on 10/2/17.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Patient was diagnosed with Bell's Palsy 2 days after receiving shot. She started noticing symptoms the day after her shot
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reported having a sore shoulder after injection with increasing pain roughly 10 days later.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N007931 with an expiration date 17-NOV-2019 and lot# N009173 with an expiration date 20-NOV-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion of 26 degrees Celsius for 1 hour and 43 minutes. There was previous excursions reported from 9 degrees Celsius to 25 degrees Celsius for 2 hours and 33 minutes and for 3 hours and 48 minutes. Data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA001676.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's medical history and drug reactions / allergies were not reported. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N012614, expiration date: 16-MAR-2018, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) lot # N015478, expiration date: 28-SEP-2019. No adverse events were reported. Administered vaccines experienced a temperature excursion of 17.4F for a time frame of 1 hour and 48 minutes. There was no previous temperature excursion. Data logger was reported as "Yes". This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1709USA014939:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's medical history and drug reactions / allergies were not reported. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N012614, expiration date: 16-MAR-2018, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) lot # N015478, expiration date: 28-SEP-2019. No adverse events were reported. Administered vaccines experienced a temperature excursion of 17.4F for a time frame of 1 hour and 48 minutes. There was no previous temperature excursion. Data logger was reported as "Yes".  This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1709USA013482:
Sex: M
Vaccine: MMR
Symptoms: Blood culture negative, Cough, Cytomegalovirus test negative, Ehrlichia test, Epstein-Barr virus test negative
Clinical narrative: Information was received from the authors in a published literature article. The authors presented a rare case of vaccine-associated measles infection in an immunocompetent, HIV-negative patient. This case concerns to a 13 months-old male patient, the child was an immunocompetent healthy patient, he had no previous adverse reactions to immunizations. His past medical history was significant for allergic rhinitis for which he had been prescribed cetirizine. On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number, expiration date, dose and route of administration were not reported) for prophylaxis. The patient did not receive any medication for 10 days prior to his admission. On an unknown date, 9 days after the vaccination, the patient presented to the hospital with a diffuse maculopapular rash, fever, cough, and coryza, the patient had no known sick contacts or any known contacts with a rash. He had no history of barn yard animal contact, no ingestion of unpasteurized dairy products, and no consumption of undercooked meats. He was placed in a negative pressure room with strict droplet precautions. On an unknown date, the patient was admitted; his vital signs upon admission were stable. He was found to be positive for Respiratory Syncytial Virus (RSV) by nasopharyngeal PCR swab testing. On examination, the patient had a full-body blanchable maculopapular rash. All routine laboratory values were normal. A blood culture showed no growth after 5 days, and a urinalysis was negative for signs of infection. A nasopharyngeal PCR test for measles was obtained; testing for Human Immunodeficiency Virus (HIV), Cytomegalovirus, Ehrlichia, EpsteinBarr virus, Parvovirus B19, and Rocky Mountain spotted fever all resulted negative. The patient's rash and congestion resolved after 5 days of supportive care. P-N was 2.103 and P/N was 30.406, both of which met criteria for a positive measles IgM  indicating an acute measles infection (a positive measles IgM capture occurs if the mean optic density of the positive control serum reacted on viral antigen (P) subtracted from the mean optic density of the negative control serum reacted on viral antigen (N) is greater than or equal to 0.10). Reverse transcriptase-polymerase chain reaction (RTPCR) testing for measles RNA from nasopharyngeal swab and measles-specific IgM from serology both returned positive 2 weeks after the patient was discharged on an unknown date. The authors considered the measles infection was related to the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). As they presumed vaccine-associated measles in an immunocompetent, pediatric patient whose HIV status was confirmed to be negative at the time of presentation. Upon internal review, the measles infection was considered a medically significant event and serious due to hospitalization.
Sex: M
Vaccine: MMR
Symptoms: HIV test negative, Laboratory test normal, Measles antibody positive, Measles post vaccine, Morbillivirus test positive
Clinical narrative: Information was received from the authors in a published literature article. The authors presented a rare case of vaccine-associated measles infection in an immunocompetent, HIV-negative patient. This case concerns to a 13 months-old male patient, the child was an immunocompetent healthy patient, he had no previous adverse reactions to immunizations. His past medical history was significant for allergic rhinitis for which he had been prescribed cetirizine. On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number, expiration date, dose and route of administration were not reported) for prophylaxis. The patient did not receive any medication for 10 days prior to his admission. On an unknown date, 9 days after the vaccination, the patient presented to the hospital with a diffuse maculopapular rash, fever, cough, and coryza, the patient had no known sick contacts or any known contacts with a rash. He had no history of barn yard animal contact, no ingestion of unpasteurized dairy products, and no consumption of undercooked meats. He was placed in a negative pressure room with strict droplet precautions. On an unknown date, the patient was admitted; his vital signs upon admission were stable. He was found to be positive for Respiratory Syncytial Virus (RSV) by nasopharyngeal PCR swab testing. On examination, the patient had a full-body blanchable maculopapular rash. All routine laboratory values were normal. A blood culture showed no growth after 5 days, and a urinalysis was negative for signs of infection. A nasopharyngeal PCR test for measles was obtained; testing for Human Immunodeficiency Virus (HIV), Cytomegalovirus, Ehrlichia, EpsteinBarr virus, Parvovirus B19, and Rocky Mountain spotted fever all resulted negative. The patient's rash and congestion resolved after 5 days of supportive care. P-N was 2.103 and P/N was 30.406, both of which met criteria for a positive measles IgM  indicating an acute measles infection (a positive measles IgM capture occurs if the mean optic density of the positive control serum reacted on viral antigen (P) subtracted from the mean optic density of the negative control serum reacted on viral antigen (N) is greater than or equal to 0.10). Reverse transcriptase-polymerase chain reaction (RTPCR) testing for measles RNA from nasopharyngeal swab and measles-specific IgM from serology both returned positive 2 weeks after the patient was discharged on an unknown date. The authors considered the measles infection was related to the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). As they presumed vaccine-associated measles in an immunocompetent, pediatric patient whose HIV status was confirmed to be negative at the time of presentation. Upon internal review, the measles infection was considered a medically significant event and serious due to hospitalization.
Sex: M
Vaccine: MMR
Symptoms: Parvovirus B19 test negative, Patient isolation, Polymerase chain reaction positive, Pyrexia, Rash maculo-papular
Clinical narrative: Information was received from the authors in a published literature article. The authors presented a rare case of vaccine-associated measles infection in an immunocompetent, HIV-negative patient. This case concerns to a 13 months-old male patient, the child was an immunocompetent healthy patient, he had no previous adverse reactions to immunizations. His past medical history was significant for allergic rhinitis for which he had been prescribed cetirizine. On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number, expiration date, dose and route of administration were not reported) for prophylaxis. The patient did not receive any medication for 10 days prior to his admission. On an unknown date, 9 days after the vaccination, the patient presented to the hospital with a diffuse maculopapular rash, fever, cough, and coryza, the patient had no known sick contacts or any known contacts with a rash. He had no history of barn yard animal contact, no ingestion of unpasteurized dairy products, and no consumption of undercooked meats. He was placed in a negative pressure room with strict droplet precautions. On an unknown date, the patient was admitted; his vital signs upon admission were stable. He was found to be positive for Respiratory Syncytial Virus (RSV) by nasopharyngeal PCR swab testing. On examination, the patient had a full-body blanchable maculopapular rash. All routine laboratory values were normal. A blood culture showed no growth after 5 days, and a urinalysis was negative for signs of infection. A nasopharyngeal PCR test for measles was obtained; testing for Human Immunodeficiency Virus (HIV), Cytomegalovirus, Ehrlichia, EpsteinBarr virus, Parvovirus B19, and Rocky Mountain spotted fever all resulted negative. The patient's rash and congestion resolved after 5 days of supportive care. P-N was 2.103 and P/N was 30.406, both of which met criteria for a positive measles IgM  indicating an acute measles infection (a positive measles IgM capture occurs if the mean optic density of the positive control serum reacted on viral antigen (P) subtracted from the mean optic density of the negative control serum reacted on viral antigen (N) is greater than or equal to 0.10). Reverse transcriptase-polymerase chain reaction (RTPCR) testing for measles RNA from nasopharyngeal swab and measles-specific IgM from serology both returned positive 2 weeks after the patient was discharged on an unknown date. The authors considered the measles infection was related to the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). As they presumed vaccine-associated measles in an immunocompetent, pediatric patient whose HIV status was confirmed to be negative at the time of presentation. Upon internal review, the measles infection was considered a medically significant event and serious due to hospitalization.
Sex: M
Vaccine: MMR
Symptoms: Respiratory syncytial virus test positive, Respiratory tract congestion, Rhinitis, Urine analysis normal
Clinical narrative: Information was received from the authors in a published literature article. The authors presented a rare case of vaccine-associated measles infection in an immunocompetent, HIV-negative patient. This case concerns to a 13 months-old male patient, the child was an immunocompetent healthy patient, he had no previous adverse reactions to immunizations. His past medical history was significant for allergic rhinitis for which he had been prescribed cetirizine. On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number, expiration date, dose and route of administration were not reported) for prophylaxis. The patient did not receive any medication for 10 days prior to his admission. On an unknown date, 9 days after the vaccination, the patient presented to the hospital with a diffuse maculopapular rash, fever, cough, and coryza, the patient had no known sick contacts or any known contacts with a rash. He had no history of barn yard animal contact, no ingestion of unpasteurized dairy products, and no consumption of undercooked meats. He was placed in a negative pressure room with strict droplet precautions. On an unknown date, the patient was admitted; his vital signs upon admission were stable. He was found to be positive for Respiratory Syncytial Virus (RSV) by nasopharyngeal PCR swab testing. On examination, the patient had a full-body blanchable maculopapular rash. All routine laboratory values were normal. A blood culture showed no growth after 5 days, and a urinalysis was negative for signs of infection. A nasopharyngeal PCR test for measles was obtained; testing for Human Immunodeficiency Virus (HIV), Cytomegalovirus, Ehrlichia, EpsteinBarr virus, Parvovirus B19, and Rocky Mountain spotted fever all resulted negative. The patient's rash and congestion resolved after 5 days of supportive care. P-N was 2.103 and P/N was 30.406, both of which met criteria for a positive measles IgM  indicating an acute measles infection (a positive measles IgM capture occurs if the mean optic density of the positive control serum reacted on viral antigen (P) subtracted from the mean optic density of the negative control serum reacted on viral antigen (N) is greater than or equal to 0.10). Reverse transcriptase-polymerase chain reaction (RTPCR) testing for measles RNA from nasopharyngeal swab and measles-specific IgM from serology both returned positive 2 weeks after the patient was discharged on an unknown date. The authors considered the measles infection was related to the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). As they presumed vaccine-associated measles in an immunocompetent, pediatric patient whose HIV status was confirmed to be negative at the time of presentation. Upon internal review, the measles infection was considered a medically significant event and serious due to hospitalization.