chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site pain, Injection site vesicles
Clinical narrative: Pt returned to clinic 8/3/17. She rec'd TDaP on 7/26/17 office visit. She states that her bicep area has been sore ever since. Today she developed a water filled blister below the bicep near site where injection was given and bruising. Pt was given amoxicillin and pain med NORCO.
Age: 26.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dyspnoea, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. received HPV-9 and T-dap at (L) deltoid on 7/25/17 that night she started to develop swelling at the site, with some pain, redness, also fatigue, mild SOB, mild sore throat, symptoms peaked on 7/29/17 then started to improve, currently all symptoms resolved, except a small bump at the site, nontender, no swelling.
Age: 26.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Oropharyngeal pain
Clinical narrative: Pt. received HPV-9 and T-dap at (L) deltoid on 7/25/17 that night she started to develop swelling at the site, with some pain, redness, also fatigue, mild SOB, mild sore throat, symptoms peaked on 7/29/17 then started to improve, currently all symptoms resolved, except a small bump at the site, nontender, no swelling.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hypotension, Syncope
Clinical narrative: 5 mins. approximately - post injection, while in the waiting room sitting in a chair, patient had syncopal episode which last approximately 2 mins. Cool compresses applied to patient's forehead. She was gently eased to the floor and her legs were elevated. She roused, then was moved - she walked with assistance - to a room. We monitored patient's BP. (she has a low baseline BP). She drank 2 juice boxes and 3 12 oz. glasses of water. She remained supine with her BP's increasing. I then did orthostatic BP's. Dr. reviewed and cleared patient to leave. We obtained a progress report the next day. Dad stated that patient was doing very well.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Dizziness, Dizziness postural, Dyspnoea, Feeling hot, Immediate post-injection reaction
Clinical narrative: Felt soreness immediately after at injection site. Woke up this morning, face seemed swollen, particularly on cheeks. Felt dizzy and light-headed. No syncope. Standing up made it worse. Denies blurred vision, shortness of breath, itchy or tightening sensation in throat. No hives. Reports that his face feels warm, no fever.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site pain, Swelling face, Throat irritation, Throat tightness, Vision blurred
Clinical narrative: Felt soreness immediately after at injection site. Woke up this morning, face seemed swollen, particularly on cheeks. Felt dizzy and light-headed. No syncope. Standing up made it worse. Denies blurred vision, shortness of breath, itchy or tightening sensation in throat. No hives. Reports that his face feels warm, no fever.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Condition aggravated, Dermatitis contact, Dizziness, Feeling hot, Immediate post-injection reaction
Clinical narrative: Felt soreness immediately after at injection site. Woke up this morning, face seemed swollen, particularly on cheeks. Felt dizzy and light-headed. No syncope. Standing up made it worse. Denies blurred vision, shortness of breath, itchy or tightening sensation in throat. No hives. Reports that his face feels warm, no fever.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site pain, Swelling face
Clinical narrative: Felt soreness immediately after at injection site. Woke up this morning, face seemed swollen, particularly on cheeks. Felt dizzy and light-headed. No syncope. Standing up made it worse. Denies blurred vision, shortness of breath, itchy or tightening sensation in throat. No hives. Reports that his face feels warm, no fever.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Rash
Clinical narrative: Pt received the 4 vaccines below. 5 minutes after they were administered the pt developed a rash on her upper body. No breathing difficulty noted. Pt assessed by provider and monitored in office. Rash gone within 20 minutes.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath both times the evening of the injection given that lasts about 2 hours. Patient just reported to us on 8/2/17 - the day 3rd injection was going to be given.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received PNEUMOVAX 23, pneumonia vaccine 10:45 AM. He came back around 4:45 PM saying he is having swelling, pain and numbness on his arm.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Allergy test positive, Asthma, Cough, Crying, Eczema
Clinical narrative: Fever developed 3 hours after injections, and baby became very sleepy. He had the fever for the next three days, and alternated between crying and sleeping. The doctor wouldn't see him and said to wait it out. Within 1 week he developed a cold with a raspy cough and was wheezy. The cough lasted about 5 days. No treatment was given. 1 week after the cough he developed eczema and had gastrointestinal problems. Over the next 2 months the eczema got progressively worse. Mother cut dairy out of her diet and it helped somewhat, but eczema was still an underlying issue. At 12 months allergy test were done, and came back very allergic to peanuts, dairy, wheat, and somewhat allergic to oats, eggs, and sesame. At 18 months he was diagnosed with viral induced asthma and given albuterol. At 2 years old a steroid maintenance inhaler was prescribed. He continued getting worse until naturopathic remedies were introduced.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Gastrointestinal disorder, Nasopharyngitis, Pyrexia, Somnolence, Viral infection
Clinical narrative: Fever developed 3 hours after injections, and baby became very sleepy. He had the fever for the next three days, and alternated between crying and sleeping. The doctor wouldn't see him and said to wait it out. Within 1 week he developed a cold with a raspy cough and was wheezy. The cough lasted about 5 days. No treatment was given. 1 week after the cough he developed eczema and had gastrointestinal problems. Over the next 2 months the eczema got progressively worse. Mother cut dairy out of her diet and it helped somewhat, but eczema was still an underlying issue. At 12 months allergy test were done, and came back very allergic to peanuts, dairy, wheat, and somewhat allergic to oats, eggs, and sesame. At 18 months he was diagnosed with viral induced asthma and given albuterol. At 2 years old a steroid maintenance inhaler was prescribed. He continued getting worse until naturopathic remedies were introduced.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Wheezing
Clinical narrative: Fever developed 3 hours after injections, and baby became very sleepy. He had the fever for the next three days, and alternated between crying and sleeping. The doctor wouldn't see him and said to wait it out. Within 1 week he developed a cold with a raspy cough and was wheezy. The cough lasted about 5 days. No treatment was given. 1 week after the cough he developed eczema and had gastrointestinal problems. Over the next 2 months the eczema got progressively worse. Mother cut dairy out of her diet and it helped somewhat, but eczema was still an underlying issue. At 12 months allergy test were done, and came back very allergic to peanuts, dairy, wheat, and somewhat allergic to oats, eggs, and sesame. At 18 months he was diagnosed with viral induced asthma and given albuterol. At 2 years old a steroid maintenance inhaler was prescribed. He continued getting worse until naturopathic remedies were introduced.
Age: 24.0
Sex: M
Vaccine: ANTH, HPV9, JEVX, SMALL
Symptoms: Erythema, Papule, Rash, Rash, Rash pruritic
Clinical narrative: This unsolicited case was received on 06 September 2015 via a third party query tool search on the VAERS database, under reference number 631620. This case involves a 24-year-old male patient who received the following vaccination on 30-MAR-2016: a first dose of ACAM2000 (batch number: VV03019C, route of administration was reported as unknown) on left arm. It was reported that, the patient denies a personal history of atopic dermatitis/eczema and any prior adverse vaccine reactions. Also reported that, the patient had no known allergies and no chronic medical conditions. Patient's family history was not reported. The patient's current illness was reported as none. Concomitant medications included vaccination with a first dose of ANTHRAX, simultaneously vaccinated with a first dose of HPV9 and was also vaccinated with a second dose of JE VACCINE (the batch number, expiry date, dose, dose in series, form, route and site of administration were not reported) on 18 March 2016. On 11 April 2016, 12 days following the vaccination, patient had experienced mildly pruritic rash (erythematous papules) over bilateral hands and fingers, erthemas, papule and rash. It was reported that, the patient denies arthralgias, myalgias, fever/chills, chest pain, malaise, fatigue, headache, pulmonary, CV, and GI symptoms. Also reported that, patient kept ACAM2000 vaccination site covered as directed and denies generalized rash. Lab data was reported as none. The corrective treatment includes high potency topical corticosteroid. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Haematuria, Henoch-Schonlein purpura nephritis, Purpura, Urinary tract infection
Clinical narrative: On the night of vaccination (Jan 11, 2017), pin-size purple spots appeared on patient's foot (top & bottom); larger spots developed on the extremities in the following days. All spots disappeared in about a week and half but the patient had reduced appetite, nose bleeds and complained of abdominal pain, the patient was diagnosed with Henoch-schonlein purpura, no lab test or medicine was given. On Feb 18th, 2017, the patient developed fever followed with vomiting and abdominal pain, and started to have visible blood in the urine following day. The patient was seen in ER, urinalysis showed proteinuria and hematuria, the doctor suspected UTI and prescribed antibiotics (Cefdinir); however, proteinuria and hematuria still persisted after antibiotics treatment, the patient was referred for pediatric nephrology evaluation. On March 08, 2017, the patient was diagnosed for Henoch-Schonlein Purpuric nephritis.  As of end of July, the patient has cleared of proteinuria but still has hematuria.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Blood albumin decreased, Blood creatine decreased, Blood urine present, Decreased appetite
Clinical narrative: On the night of vaccination (Jan 11, 2017), pin-size purple spots appeared on patient's foot (top & bottom); larger spots developed on the extremities in the following days. All spots disappeared in about a week and half but the patient had reduced appetite, nose bleeds and complained of abdominal pain, the patient was diagnosed with Henoch-schonlein purpura, no lab test or medicine was given. On Feb 18th, 2017, the patient developed fever followed with vomiting and abdominal pain, and started to have visible blood in the urine following day. The patient was seen in ER, urinalysis showed proteinuria and hematuria, the doctor suspected UTI and prescribed antibiotics (Cefdinir); however, proteinuria and hematuria still persisted after antibiotics treatment, the patient was referred for pediatric nephrology evaluation. On March 08, 2017, the patient was diagnosed for Henoch-Schonlein Purpuric nephritis.  As of end of July, the patient has cleared of proteinuria but still has hematuria.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Epistaxis, Glomerular filtration rate normal, Haematuria, Henoch-Schonlein purpura, Henoch-Schonlein purpura nephritis
Clinical narrative: On the night of vaccination (Jan 11, 2017), pin-size purple spots appeared on patient's foot (top & bottom); larger spots developed on the extremities in the following days. All spots disappeared in about a week and half but the patient had reduced appetite, nose bleeds and complained of abdominal pain, the patient was diagnosed with Henoch-schonlein purpura, no lab test or medicine was given. On Feb 18th, 2017, the patient developed fever followed with vomiting and abdominal pain, and started to have visible blood in the urine following day. The patient was seen in ER, urinalysis showed proteinuria and hematuria, the doctor suspected UTI and prescribed antibiotics (Cefdinir); however, proteinuria and hematuria still persisted after antibiotics treatment, the patient was referred for pediatric nephrology evaluation. On March 08, 2017, the patient was diagnosed for Henoch-Schonlein Purpuric nephritis.  As of end of July, the patient has cleared of proteinuria but still has hematuria.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Protein total decreased, Protein urine present, Proteinuria, Pyrexia, Red blood cells urine positive
Clinical narrative: On the night of vaccination (Jan 11, 2017), pin-size purple spots appeared on patient's foot (top & bottom); larger spots developed on the extremities in the following days. All spots disappeared in about a week and half but the patient had reduced appetite, nose bleeds and complained of abdominal pain, the patient was diagnosed with Henoch-schonlein purpura, no lab test or medicine was given. On Feb 18th, 2017, the patient developed fever followed with vomiting and abdominal pain, and started to have visible blood in the urine following day. The patient was seen in ER, urinalysis showed proteinuria and hematuria, the doctor suspected UTI and prescribed antibiotics (Cefdinir); however, proteinuria and hematuria still persisted after antibiotics treatment, the patient was referred for pediatric nephrology evaluation. On March 08, 2017, the patient was diagnosed for Henoch-Schonlein Purpuric nephritis.  As of end of July, the patient has cleared of proteinuria but still has hematuria.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Skin discolouration, Urinary casts, Urinary sediment abnormal, Urinary tract infection, Urine analysis abnormal
Clinical narrative: On the night of vaccination (Jan 11, 2017), pin-size purple spots appeared on patient's foot (top & bottom); larger spots developed on the extremities in the following days. All spots disappeared in about a week and half but the patient had reduced appetite, nose bleeds and complained of abdominal pain, the patient was diagnosed with Henoch-schonlein purpura, no lab test or medicine was given. On Feb 18th, 2017, the patient developed fever followed with vomiting and abdominal pain, and started to have visible blood in the urine following day. The patient was seen in ER, urinalysis showed proteinuria and hematuria, the doctor suspected UTI and prescribed antibiotics (Cefdinir); however, proteinuria and hematuria still persisted after antibiotics treatment, the patient was referred for pediatric nephrology evaluation. On March 08, 2017, the patient was diagnosed for Henoch-Schonlein Purpuric nephritis.  As of end of July, the patient has cleared of proteinuria but still has hematuria.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Urine protein/creatinine ratio increased, Vomiting, White blood cells urine positive
Clinical narrative: On the night of vaccination (Jan 11, 2017), pin-size purple spots appeared on patient's foot (top & bottom); larger spots developed on the extremities in the following days. All spots disappeared in about a week and half but the patient had reduced appetite, nose bleeds and complained of abdominal pain, the patient was diagnosed with Henoch-schonlein purpura, no lab test or medicine was given. On Feb 18th, 2017, the patient developed fever followed with vomiting and abdominal pain, and started to have visible blood in the urine following day. The patient was seen in ER, urinalysis showed proteinuria and hematuria, the doctor suspected UTI and prescribed antibiotics (Cefdinir); however, proteinuria and hematuria still persisted after antibiotics treatment, the patient was referred for pediatric nephrology evaluation. On March 08, 2017, the patient was diagnosed for Henoch-Schonlein Purpuric nephritis.  As of end of July, the patient has cleared of proteinuria but still has hematuria.
Age: 44.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Flushing, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 44 year old female patient with an allergy to neomycin and latex. The patient did not have a pertinent medical history.  Concomitant therapies included prednisone and diphenhydramine hydrochloride (BENADRYL).   On 10-JUL-2017 she was vaccinated with M-M-R II (lot # M045395, expiration date 14-NOV-2018), subcutaneously; that was reconstituted with sterile diluent (STERILE DILUENT) (Lot# M034194, expiration date 25-FEB-2019), for prophylaxis. Approximately 45 to 50 minutes after receiving the vaccination the patient began to experience throat swelling and tingling in the mouth and lips.  She went to the emergency room and was treated with diphenhydramine hydrochloride (BENADRYL), cetirizine (ZYRTEC) and famotidine (PEPCID) (dosage and route of administration unknown). On 11-JUL-2017 the patient returned to the emergency room with throat swelling, tingling in the mouth and lips and flushing in unspecified areas of the body. Treatment included prednisone, diphenhydramine hydrochloride (BENADRYL), cetirizine (ZYRTEC) and famotidine (PEPCID) and the patient was placed on an unspecified dosing schedule of these medications upon discharge from the emergency room. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Computerised tomogram, Loss of consciousness, Seizure like phenomena, Urine analysis
Clinical narrative: At 15:15hr patient fainted while standing at front desk scheduling follow up appointment. Patient was talking on her cell phone. 911 was called at 15:16hr. patient was attended immediately. Alcohol swab was placed close to patient's nose. Patient recovered consciousness and helped herself stand up. Patient was brought to examination room, vital signs at 15:25hr HR=60x' BP 129/80 O2Sat 99%. BP 129/80. Paramedics arrived at approximately 15:30hr. Interrogated patient and mother. Patient stood up and walked to stretcher where patient was transported to local Emergency Room Hospital, West ER was notified
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Altered state of consciousness, Computerised tomogram head normal, Pregnancy test urine negative, Spinal X-ray normal, Syncope
Clinical narrative: At 15:15hr patient fainted while standing at front desk scheduling follow up appointment. Patient was talking on her cell phone. 911 was called at 15:16hr. patient was attended immediately. Alcohol swab was placed close to patient's nose. Patient recovered consciousness and helped herself stand up. Patient was brought to examination room, vital signs at 15:25hr HR=60x' BP 129/80 O2Sat 99%. BP 129/80. Paramedics arrived at approximately 15:30hr. Interrogated patient and mother. Patient stood up and walked to stretcher where patient was transported to local Emergency Room Hospital, West ER was notified
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Urine analysis abnormal
Clinical narrative: At 15:15hr patient fainted while standing at front desk scheduling follow up appointment. Patient was talking on her cell phone. 911 was called at 15:16hr. patient was attended immediately. Alcohol swab was placed close to patient's nose. Patient recovered consciousness and helped herself stand up. Patient was brought to examination room, vital signs at 15:25hr HR=60x' BP 129/80 O2Sat 99%. BP 129/80. Paramedics arrived at approximately 15:30hr. Interrogated patient and mother. Patient stood up and walked to stretcher where patient was transported to local Emergency Room Hospital, West ER was notified
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pt contacted his primary care doctor the day after he had the PNEUMOVAX vaccination w/ complaints of flu-like symptoms. Also, the area around the injection site was red and swollen. He was physically seen 3 days after vaccination and was diagnosed w/ cellulitis.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Adverse event, Extra dose administered
Clinical narrative: Information has been received on 28-JUN-2017 from an office manager via a company representative regarding a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were unknown. On either 27-JUN-2017 or 28-JUN-2017, the patient received both VARIVAX (lot number and expiration unknown) subcutaneous for prophylaxis and PROQUAD (lot number and expiration unknown) subcutaneous for prophylaxis. The reporter stated the patient received a "double dose of varicella" on either 27-JUN-2017 or 28-JUN-2017. So far, the patient has not experienced any adverse effects from this. As of 28-JUN-2017, it is unknown if the patient will continue to receive the VARIVAX or PROQUAD and the outcome of receiving both vaccines was unknown. Follow-up information was received on 30-JUN-2017 from an office manager. On 27-JUN-2017 the patient received both VARIVAX (lot number M041513 and expiration date 11-OCT-2018) and PROQUAD (lot number M037010 and expiration date 21-FEB-2018). No adverse effects reported. No further information was provided. Follow-up information was received on 03-JUL-2017,  from  a physician via an office manager. It was reported  that the patient was vaccinated on 27-JUN-2017, and a properly stored sterile diluent (DILUENT MRK) was used to reconstituted both VARIVAX (lot number M041513 and expiration date 11-OCT-2018) and PROQUAD (lot number M037010 and expiration date 21-FEB-2018). An on unspecified date in 2017, the patient experienced an adverse event (unspecified details). The patient's outcome for adverse event was unknown.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report has been received from a nurse referring to a one year old male patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 10-JUL-2017, the patient was vaccinated with VAQTA (dose and route were not reported) lot # N005274 with expiration date 03-APR-2018, for prophylaxis. In July 2017, the patient developed "swelling and redness" at injection site that "kept getting worse". The patient was seen in physician's office on 12-JUL-2017 and received unspecified treatment. The patient was currently not recovered. The causality between events with VAQTA was not provided.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Differential white blood cell count, Full blood count, Hyperhidrosis, Injection site discomfort
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 39 year old male patient. The patient's concurrent conditions included vitamin D deficiency, varicose vein, onychomycosis, insomnia, human immunodeficiency virus (HIV), generalized anxiety disorder, genital herpes, rhinitis allergic and shift work disorder. Concomitant medication included vilazodone hydrochloride (VIIBRYD), valacyclovir, trazodone, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate (ODEFSEY), eszopiclone (LUNESTA), vitamin D2 and tadalafil (CIALIS). On 11-JUL-2017, the patient received a dose of PNEUMOVAX 23 , lot # N010109, expiration date 20-NOV-2018 (dose and route not reported), in the right deltoid for prophylaxis. He felt discomfort at the injection site, had a fever of 102.8 (unit not provided) and had sweats on the evening of 11-JUL-2017. Then he was relieved with a cool bath. The patient called the office on 12-JUL-2017 to report "injection-site pain and fever of 101(unit not provided)" and was given a prescription for meloxicam (MOBIC). On an unspecified date in July 2017, the patient went to the emergency room at a hospital for pain, swelling and redness at the injection site. He received intravenous fluids and was released to home on an unspecified date. After the emergency room visit, on an unspecified date in July 2017, the patient's upper deltoid had redness, swelling and was warm to touch starting from his shoulder to just above his elbow. He was prescribed warm compress. He received laboratory tests including ultrasound of the right arm, complete blood count (cbc) with differential, blood cultures and comprehensive metabolic panel. The patient started on doxycycline on 14-JUL-2017. On 15-JUL-2017, ultrasound report showed mild swelling with no discreet fluid collection. The patient was tolerating doxycycline and the swelling, tenderness and pain in his arm had improved. The patient missed three days of work. At the time of the report, the patient was recovering from all of events. The causality between the events and PNEUMOVAX 23 was not reported. This is one of several report received the same source.; Sender's Comments:  US-009507513-1707USA011016:
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Metabolic function test
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 39 year old male patient. The patient's concurrent conditions included vitamin D deficiency, varicose vein, onychomycosis, insomnia, human immunodeficiency virus (HIV), generalized anxiety disorder, genital herpes, rhinitis allergic and shift work disorder. Concomitant medication included vilazodone hydrochloride (VIIBRYD), valacyclovir, trazodone, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate (ODEFSEY), eszopiclone (LUNESTA), vitamin D2 and tadalafil (CIALIS). On 11-JUL-2017, the patient received a dose of PNEUMOVAX 23 , lot # N010109, expiration date 20-NOV-2018 (dose and route not reported), in the right deltoid for prophylaxis. He felt discomfort at the injection site, had a fever of 102.8 (unit not provided) and had sweats on the evening of 11-JUL-2017. Then he was relieved with a cool bath. The patient called the office on 12-JUL-2017 to report "injection-site pain and fever of 101(unit not provided)" and was given a prescription for meloxicam (MOBIC). On an unspecified date in July 2017, the patient went to the emergency room at a hospital for pain, swelling and redness at the injection site. He received intravenous fluids and was released to home on an unspecified date. After the emergency room visit, on an unspecified date in July 2017, the patient's upper deltoid had redness, swelling and was warm to touch starting from his shoulder to just above his elbow. He was prescribed warm compress. He received laboratory tests including ultrasound of the right arm, complete blood count (cbc) with differential, blood cultures and comprehensive metabolic panel. The patient started on doxycycline on 14-JUL-2017. On 15-JUL-2017, ultrasound report showed mild swelling with no discreet fluid collection. The patient was tolerating doxycycline and the swelling, tenderness and pain in his arm had improved. The patient missed three days of work. At the time of the report, the patient was recovering from all of events. The causality between the events and PNEUMOVAX 23 was not reported. This is one of several report received the same source.; Sender's Comments:  US-009507513-1707USA011016:
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Ultrasound scan abnormal
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 39 year old male patient. The patient's concurrent conditions included vitamin D deficiency, varicose vein, onychomycosis, insomnia, human immunodeficiency virus (HIV), generalized anxiety disorder, genital herpes, rhinitis allergic and shift work disorder. Concomitant medication included vilazodone hydrochloride (VIIBRYD), valacyclovir, trazodone, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate (ODEFSEY), eszopiclone (LUNESTA), vitamin D2 and tadalafil (CIALIS). On 11-JUL-2017, the patient received a dose of PNEUMOVAX 23 , lot # N010109, expiration date 20-NOV-2018 (dose and route not reported), in the right deltoid for prophylaxis. He felt discomfort at the injection site, had a fever of 102.8 (unit not provided) and had sweats on the evening of 11-JUL-2017. Then he was relieved with a cool bath. The patient called the office on 12-JUL-2017 to report "injection-site pain and fever of 101(unit not provided)" and was given a prescription for meloxicam (MOBIC). On an unspecified date in July 2017, the patient went to the emergency room at a hospital for pain, swelling and redness at the injection site. He received intravenous fluids and was released to home on an unspecified date. After the emergency room visit, on an unspecified date in July 2017, the patient's upper deltoid had redness, swelling and was warm to touch starting from his shoulder to just above his elbow. He was prescribed warm compress. He received laboratory tests including ultrasound of the right arm, complete blood count (cbc) with differential, blood cultures and comprehensive metabolic panel. The patient started on doxycycline on 14-JUL-2017. On 15-JUL-2017, ultrasound report showed mild swelling with no discreet fluid collection. The patient was tolerating doxycycline and the swelling, tenderness and pain in his arm had improved. The patient missed three days of work. At the time of the report, the patient was recovering from all of events. The causality between the events and PNEUMOVAX 23 was not reported. This is one of several report received the same source.; Sender's Comments:  US-009507513-1707USA011016:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of an unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (dose, route of administration, lot# and expiry date were not reported) for prophylaxis. Temperature excursion was between -9 degrees Ceslius to 8 degrees Celsius (-1.3 degrees Celsius) within time frame: 2 hours and 40 minutes. Digital data logger was not involved. Concomitant therapies included sterile diluent that was not involved in temperature excursion. No adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates in June 2017 (reported as within last month), the patients were vaccinated with PNEUMOVAX 23 (dosing details, route, lot/batch# were unknown) for prophylaxis. On unknown dates in 2017, the patients experienced redness and soreness (pain) that extended beyond the injection site which lasted for a couple of days. The events have usually resolved after a couple of days (unknown date in 2017). Causality assessment was not provided by the reporter. No product quality complaint was involved.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 28-JUL-2014 the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot # J015378 dose 1 for prophylaxis.  Other suspect therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On SEP-2014 the patient experienced inappropriate schedule of drug administration. On 25-SEP-2015 the patient experienced interchange of vaccine products. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration, no adverse event and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration to be not related to GARDASIL 9 and GARDASIL. The reporter considered no adverse event and interchange of vaccine products to be not related to GARDASIL and GARDASIL 9.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1708USA000471: US-009507513-1707USA004998: US-009507513-1708USA000473: US-009507513-1708USA000474: US-009507513-1708USA000475:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA000471: US-009507513-1707USA004998: US-009507513-1708USA000472: US-009507513-1708USA000474: US-009507513-1708USA000475:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708 USA000471: US-009507513-1708USA000472: US-009507513-1707USA004998: US-009507513-1708USA000473: US-009507513-1708USA000475:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA000474: US-009507513-1707USA004998: US-009507513-1708USA000472: US-009507513-1708USA000473:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age.  On 08-JUL-2017 the patient was vaccinated with one dose of improperly stored ZOSTAVAX 19400 PFU, lot # N009777, expiration date: 04-MAR-2017) (route and dose# unspecified) for prophylaxis. Temperature and time frame: 6°F to l4°F for 5 Hours 15 Minutes respectively. There was previous temperature excursion. The call was because of a data logger. Concomitant therapies included sterile diluent (DILUENT MRK INJ). The sterile diluent (DILUENT MRK INJ) did not undergo a temperature excursion. No adverse effects reported. No additional information provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 31-JUL-2017 the patient was vaccinated with incorrectly stored PNEUMOVAX 23 lot # M042324 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 to 77 degrees Fahrenheit for 19 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated improperly stored dose of PROQUAD lot # N001488, expiration date 12-JUL-2018, single dose, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent (MERCK). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 7 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional  refers to a patient of unknown age and gender. On 01-AUG-2017,  the patient was inadvertently vaccinated with an expired dose of M-M-R II, human serum albumin (HSA), lot number M001200, expiration date 28-AUG-2016, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 28-JUL-2017 the patient was vaccinated with GARDASIL 9 dose 3 for prophylaxis. On 28-JUL-2017, 6 months 9 days after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with expired dose of PROQUAD (lot # M003436, expiry date: 19-JUL-2017) reconstituted with sterile diluent (Manufacturer unknown) (lot # and expiry date were unknown) for prophylaxis. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Facial paralysis, Herpes zoster, Injury
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for the prevention of shingles. Within six months of receiving ZOSTAVAX, the patient developed a rash and pain and was subsequently diagnosed with shingles (date not reported). The patient's conditioned subsequently developed into Bell's palsy on her right side and then her left side. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX product. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further as a result, the patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. The outcome of the events was not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Physical disability, Quality of life decreased, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for the prevention of shingles. Within six months of receiving ZOSTAVAX, the patient developed a rash and pain and was subsequently diagnosed with shingles (date not reported). The patient's conditioned subsequently developed into Bell's palsy on her right side and then her left side. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX product. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further as a result, the patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. The outcome of the events was not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. No adverse effects reported. No additional information was provided. Temperature: 2°C to 8°C (1.8C) Time frame: 42 minutes. Data logger was used. Previous temperature excursion? Yes 0°C to 1°C for 1 hour and 56 minutes, 9°C to 25°C (11.4C) for 1 hour and 41 minutes. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M043582, expiration date 28-OCT-2018; dose and route were unknown) reconstituted with properly stored sterile diluent (lot # was unknown) for prophylaxis. No adverse effects were reported. Data logger was involved. The vaccines stored under -9 Celsius degree to 8 Celsius degree for 4 hours 57 minutes. Previous temperature excursion was -9 Celsius degree to 8 Celsius degree for 2 hours 46 minutes.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to two patients of unknown age and gender.   On 31-JUL-2017, the patients were vaccinated with improperly stored ROTATEQ (lot # M038728, expiration date 28-APR-2018; dose was unknown) orally for prophylaxis. Both doses of ROTATEQ administered after prior excursion but before current excursion. No adverse effects were reported.  Date logger was involved. The previous temperature excursion was 47 Fahrenheit degree to 77 Fahrenheit degree for 2 hours 10 minutes. Temperature excursion was 47 Fahrenheit degree to 77 Fahrenheit degree for 35 hours.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pt had PNEUMOVAX injected on 8/1/17. Pt contacted his PCP the following day w/ complaints of flu-like symptoms. Also, the area around the injection site was red and swollen. Pt was seen by his provider on 8/3/17 and diagnosed w/ cellulitis.