chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager referring to a 12 months old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On an unknown date, the patients were vaccinated with Oka/Merck VARIVAX lot # N024567, expiration date of 07-SEP-2019, for prophylaxis (strength, dose, route and anatomical location were not provided). No adverse events reported. The vaccine was exposed to a temperature range of 39.5°F, during a time frame of 15 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1802USA012116: US-009507513-1802USA011938.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager referring to a 12 months old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On an unknown date, the patients were vaccinated with VARIVAX lot # N024567, expiration date of 07-SEP-2019, for prophylaxis (strength, dose, route and anatomical location were not provided). No adverse events reported. The vaccine was exposed to a temperature range of 39.5°F, during a time frame of 15 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1802USA011938: US-009507513-1802USA012115.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N025929 and expiration date on 18-MAR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). The sterile diluent (MERCK) lot # M017324 and expiration date on 25-SEP-2018, used to reconstitute the vaccine was properly stored. The administered dose of the vaccine experienced a temperature excursion of -14°C to-10°C for 22 minutes as recorded by a data logger, with a previous temperature excursion report in the range between -14°C to -10°C  for 22 minutes. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA011935.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-NOV-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #M044953, expiry date: 27-FEB-2019). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012320: US-009507513-1802USA012323: US-009507513-1802USA012326.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-DEC-2017, the patient was vaccinated with improperly stored Oka/Merck VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #M026303, expiry date: 11-MAR-2019) (incorrect product storage). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012317: US-009507513-1802USA012323: US-009507513-1802USA012326.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-JAN-2018, the patient was vaccinated with improperly stored VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #N021583, expiry date: 08-NOV-2019). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012317: US-009507513-1802USA012320: US-009507513-1802USA012326.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #N026288, expiry date: 08-FEB-2020). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012320: US-009507513-1802USA012323: US-009507513-1802USA012317.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Muscle fatigue
Clinical narrative: Pain and tenderness - severe for approx two days, then moderate for three days; ibuprofen and/or TYLENOL lessened pain slightly. Redness - began after one day, still apparent on day five; redness is from top of shoulder down to almost elbow. Swelling - began after one day, still apparent on day five; swelling just in shoulder area. Muscle pain/soreness and fatigue - began on day one and last through day four. Fever and chills - began after one day, continued through second day. Headache - slight headache began after one day, has continued through day five. Nausea - began same day as injection and continued through day four. Stiffness - began day one and has continued through day five.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Pain and tenderness - severe for approx two days, then moderate for three days; ibuprofen and/or TYLENOL lessened pain slightly. Redness - began after one day, still apparent on day five; redness is from top of shoulder down to almost elbow. Swelling - began after one day, still apparent on day five; swelling just in shoulder area. Muscle pain/soreness and fatigue - began on day one and last through day four. Fever and chills - began after one day, continued through second day. Headache - slight headache began after one day, has continued through day five. Nausea - began same day as injection and continued through day four. Stiffness - began day one and has continued through day five.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tenderness
Clinical narrative: Pain and tenderness - severe for approx two days, then moderate for three days; ibuprofen and/or TYLENOL lessened pain slightly. Redness - began after one day, still apparent on day five; redness is from top of shoulder down to almost elbow. Swelling - began after one day, still apparent on day five; swelling just in shoulder area. Muscle pain/soreness and fatigue - began on day one and last through day four. Fever and chills - began after one day, continued through second day. Headache - slight headache began after one day, has continued through day five. Nausea - began same day as injection and continued through day four. Stiffness - began day one and has continued through day five.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling, Tenderness
Clinical narrative: Signs and Symptoms: Tender, Itchy, Redness, Pain in the area, and Swelling. Sx and Sx start on Saturday night until today.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states fever of 102 degrees F.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent was used to reconstitute the PROQUAD. On 12-FEB-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units, frequency and route was not reported) (lot # N022973 and expiration date: 01-FEB-2019) at the temperature from -14 degree Celsius (C) to -10 C for 15 minutes and -9 C to 8 C (-1.7 C) for 1 hour 8 minutes. No adverse effects were reported and no further information was provided. No product quality complaint was involved. The call was because of digital data logger. There was no previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health care worker, referring to 5 unspecified patients of unknown age and gender. No information was provided regarding medical history, concurrent conditions or concomitant medications of the patients. It was reported by the health care worker that, since October 2017, the 5 unspecified patients received improperly stored doses of ROTATEQ Lot # N005080, expiration date 17-NOV-2018; Lot # N005080, expiration date 03-OCT-2018 for prophylaxis (dose and route of administration were not reported). The administered doses of the vaccines experienced a temperature excursion of 47°F to 77°F (49.8°F) for 8 hours, as recorded by a data logger. The vaccines had previous temperature excursions 47°F to 77°F (47.8F) for 14 hours; 47°F to 77°F (7.8F) for 8 hours; 47°F to 77°F (47.4) for 12 hours 20 minutes and 47°F to 77°F (47.4) for 9 hours 5 minutes.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Feeding tube user, Gastrointestinal tube insertion, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: All muscles affected, on oxygen, feeding tube still in, sweats a lot, memory affected, difficulty showing, was in wheelchair, still on walker, swallowing problem.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Memory impairment, Muscle disorder, Walking aid user, Wheelchair user, X-ray
Clinical narrative: All muscles affected, on oxygen, feeding tube still in, sweats a lot, memory affected, difficulty showing, was in wheelchair, still on walker, swallowing problem.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Audiogram, Chiropractic, Computerised tomogram head, Differential white blood cell count
Clinical narrative: 10-10-15 ER (Em. Room) vomiting/dysfunctional headache/disorientated/vision. Procedure/tests: CBC and auto differential, CT head brain scan, comprehensive metabolic panel; ECG. Diagnosis: Benign paroxysmal positional vertigo, Unspecified laterality labyrinthitis. Treatment: 3 Prescriptions Prescribed. Additional information: 10-12-15 Chiropractor thru 05-23-16, 10-14-15 Physical Therapy thru 06-22-2016, 10-29-15 Audiology Hearing Test, 11-04-15 Audiology Videonystagmography Test, 11-05-15 Follow-Up Ear, Nose, Throat Clinic, 12-08-15 Follow-Up Ear, Nose, Throat Clinic, 12-11-15 Appt Neurology Medical Group, 12-24-15 MRI scan 3 imaging test, 01-07-16 Follow-up Neurologist, 01-20-16 MRI scan 1 imaging test, 01-09-16 Optometrist (Eye Test), 01-21-16 Follow-up Neurologist-MD, 01-27-16 PCP-General MD, 02-03-16 Follow-up Neurologist-MD, 02-17-16 Follow-up Neurologist-MD, 03-09-16 Follow-up Neurologist-MD, Referral to Hospital, 03-28-16 Hospital Confirmation, 06-27-16 Neurology Specialist Appt, 06-27-16 Neuro-Otology Specialist Appt, 08-27-16 Wellness/Biometric screening, 08-29-16 Follow-up Neurology Specialists, 09-23-16 Audiogram Hearing Test, 11-18-16 Follow-up Neurology Specialist (Letter), 01-10-17 thru 02-16-18 Follow-up Neurology Specialist (Letter), Follow-up Therapy (In home), Patient has "not" recovered from adverse diagnoses/event.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Electrocardiogram, Electronystagmogram, Full blood count, Headache
Clinical narrative: 10-10-15 ER (Em. Room) vomiting/dysfunctional headache/disorientated/vision. Procedure/tests: CBC and auto differential, CT head brain scan, comprehensive metabolic panel; ECG. Diagnosis: Benign paroxysmal positional vertigo, Unspecified laterality labyrinthitis. Treatment: 3 Prescriptions Prescribed. Additional information: 10-12-15 Chiropractor thru 05-23-16, 10-14-15 Physical Therapy thru 06-22-2016, 10-29-15 Audiology Hearing Test, 11-04-15 Audiology Videonystagmography Test, 11-05-15 Follow-Up Ear, Nose, Throat Clinic, 12-08-15 Follow-Up Ear, Nose, Throat Clinic, 12-11-15 Appt Neurology Medical Group, 12-24-15 MRI scan 3 imaging test, 01-07-16 Follow-up Neurologist, 01-20-16 MRI scan 1 imaging test, 01-09-16 Optometrist (Eye Test), 01-21-16 Follow-up Neurologist-MD, 01-27-16 PCP-General MD, 02-03-16 Follow-up Neurologist-MD, 02-17-16 Follow-up Neurologist-MD, 03-09-16 Follow-up Neurologist-MD, Referral to Hospital, 03-28-16 Hospital Confirmation, 06-27-16 Neurology Specialist Appt, 06-27-16 Neuro-Otology Specialist Appt, 08-27-16 Wellness/Biometric screening, 08-29-16 Follow-up Neurology Specialists, 09-23-16 Audiogram Hearing Test, 11-18-16 Follow-up Neurology Specialist (Letter), 01-10-17 thru 02-16-18 Follow-up Neurology Specialist (Letter), Follow-up Therapy (In home), Patient has "not" recovered from adverse diagnoses/event.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Imaging procedure, Labyrinthitis, Metabolic function test, Nuclear magnetic resonance imaging, Ophthalmological examination
Clinical narrative: 10-10-15 ER (Em. Room) vomiting/dysfunctional headache/disorientated/vision. Procedure/tests: CBC and auto differential, CT head brain scan, comprehensive metabolic panel; ECG. Diagnosis: Benign paroxysmal positional vertigo, Unspecified laterality labyrinthitis. Treatment: 3 Prescriptions Prescribed. Additional information: 10-12-15 Chiropractor thru 05-23-16, 10-14-15 Physical Therapy thru 06-22-2016, 10-29-15 Audiology Hearing Test, 11-04-15 Audiology Videonystagmography Test, 11-05-15 Follow-Up Ear, Nose, Throat Clinic, 12-08-15 Follow-Up Ear, Nose, Throat Clinic, 12-11-15 Appt Neurology Medical Group, 12-24-15 MRI scan 3 imaging test, 01-07-16 Follow-up Neurologist, 01-20-16 MRI scan 1 imaging test, 01-09-16 Optometrist (Eye Test), 01-21-16 Follow-up Neurologist-MD, 01-27-16 PCP-General MD, 02-03-16 Follow-up Neurologist-MD, 02-17-16 Follow-up Neurologist-MD, 03-09-16 Follow-up Neurologist-MD, Referral to Hospital, 03-28-16 Hospital Confirmation, 06-27-16 Neurology Specialist Appt, 06-27-16 Neuro-Otology Specialist Appt, 08-27-16 Wellness/Biometric screening, 08-29-16 Follow-up Neurology Specialists, 09-23-16 Audiogram Hearing Test, 11-18-16 Follow-up Neurology Specialist (Letter), 01-10-17 thru 02-16-18 Follow-up Neurology Specialist (Letter), Follow-up Therapy (In home), Patient has "not" recovered from adverse diagnoses/event.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo positional, Visual impairment, Vomiting
Clinical narrative: 10-10-15 ER (Em. Room) vomiting/dysfunctional headache/disorientated/vision. Procedure/tests: CBC and auto differential, CT head brain scan, comprehensive metabolic panel; ECG. Diagnosis: Benign paroxysmal positional vertigo, Unspecified laterality labyrinthitis. Treatment: 3 Prescriptions Prescribed. Additional information: 10-12-15 Chiropractor thru 05-23-16, 10-14-15 Physical Therapy thru 06-22-2016, 10-29-15 Audiology Hearing Test, 11-04-15 Audiology Videonystagmography Test, 11-05-15 Follow-Up Ear, Nose, Throat Clinic, 12-08-15 Follow-Up Ear, Nose, Throat Clinic, 12-11-15 Appt Neurology Medical Group, 12-24-15 MRI scan 3 imaging test, 01-07-16 Follow-up Neurologist, 01-20-16 MRI scan 1 imaging test, 01-09-16 Optometrist (Eye Test), 01-21-16 Follow-up Neurologist-MD, 01-27-16 PCP-General MD, 02-03-16 Follow-up Neurologist-MD, 02-17-16 Follow-up Neurologist-MD, 03-09-16 Follow-up Neurologist-MD, Referral to Hospital, 03-28-16 Hospital Confirmation, 06-27-16 Neurology Specialist Appt, 06-27-16 Neuro-Otology Specialist Appt, 08-27-16 Wellness/Biometric screening, 08-29-16 Follow-up Neurology Specialists, 09-23-16 Audiogram Hearing Test, 11-18-16 Follow-up Neurology Specialist (Letter), 01-10-17 thru 02-16-18 Follow-up Neurology Specialist (Letter), Follow-up Therapy (In home), Patient has "not" recovered from adverse diagnoses/event.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Bronchial wall thickening, Chest X-ray abnormal, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Fever to 103 7 hours after the injection was given and fever 9 hours after the vaccine was given. There is no previous history of seizure and no family history of seizures.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Chest X-ray normal, Electrocardiogram normal, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Symptoms started at 1030 PM 2/23/2018 and worsened. Symptoms were severe stiffness in neck and top of shoulder, vomiting and nausea. Could not move my neck due to pain and the stiffness. Went to the emergency room via ambulance around 1200 AM 2/24/2018. TORADOL 30 mg was given through hand IV at 2:22 AM 2/24/2018. ZOFRAN 4 mg was given through hand IV at 2:22 AM 2/24/2018.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Neck pain, Vomiting, White blood cell count increased
Clinical narrative: Symptoms started at 1030 PM 2/23/2018 and worsened. Symptoms were severe stiffness in neck and top of shoulder, vomiting and nausea. Could not move my neck due to pain and the stiffness. Went to the emergency room via ambulance around 1200 AM 2/24/2018. TORADOL 30 mg was given through hand IV at 2:22 AM 2/24/2018. ZOFRAN 4 mg was given through hand IV at 2:22 AM 2/24/2018.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Abdominal pain, Anxiety, Flushing, Paraesthesia
Clinical narrative: A few minutes after receiving the immunizations, he developed generalized flushing, left abdominal pain with paresthesias and a sense that something bad was happening. No dyspnea. Gave epi and transferred to Urgent Care. Referring to Allergy.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Hallucination, auditory, Hallucination, visual, Suicide attempt
Clinical narrative: A call was placed to the office on 02/12/17 via Agency, she stated that patient was baker acted and sent to behavioral unit after he received the flu shot, he was seeing things and hearing voices tell him to kill and he tried to hang himself.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-FEB-2018, the patient was vaccinated with PROQUAD (dose and route of administration were not reported) lot # N023966, expiration date: 28-FEB-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). The vaccine was stored in 11 degrees Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. The excursion was detected by a Digital Data Logger. There was no adverse effects reported.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Headache, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Patient had sore, itchy arm and inflammation down from the injection site to the elbow. She also had a headache. She iced the arm and took ADVIL, which helped her symptoms. This has fully resolved by now. Patient contacted her doctor for documentation and check-up. Pt. states reaction only occurred in left arm.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Back pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Dizzy, shaky, hives, shortness of breath like (asthma) joint pain, headache (bad) vision change (blurry) back, neck pain, fever and ER they found no other reason than immunization. She sleeps sometimes 19-20 hrs a day. Joints hurt now.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Neck pain, Pyrexia, Somnolence, Tremor, Urticaria
Clinical narrative: Dizzy, shaky, hives, shortness of breath like (asthma) joint pain, headache (bad) vision change (blurry) back, neck pain, fever and ER they found no other reason than immunization. She sleeps sometimes 19-20 hrs a day. Joints hurt now.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: Dizzy, shaky, hives, shortness of breath like (asthma) joint pain, headache (bad) vision change (blurry) back, neck pain, fever and ER they found no other reason than immunization. She sleeps sometimes 19-20 hrs a day. Joints hurt now.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: Arm is still sore and itchy, raised red area around injection site, great fatigue hard to wake up, not usual.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Arm is still sore and itchy, raised red area around injection site, great fatigue hard to wake up, not usual.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Dizziness, Nausea, Unresponsive to stimuli
Clinical narrative: Client was given the three vaccines at 0835. At 0836 client stated she was feeling "dizzy" and  "lightheaded". Client could not hold head up on her own, would not open eyes, and would not respond to her name. Client was breathing. Cold pack placed on neck and fan placed in front of client. Client stated she felt "nauseas." Client was then transferred to laying position on cot with knees in bent position around 0840. Blood pressure reading taken at 0845 measuring 110/74. Pulse measured at 74 bpm. Client oriented to person, place, disoriented to time. Around 0855 client able to stand from cot  and transfer self to sit in chair with out dizziness. Able to drink juice. At 0858 client walked out of clinic room without assistance to sit in waiting room. Advised to sit for ten more minutes Client walked out of building at 0905.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Generalised vaccinia, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Patient appears to be having a mild generalized vaccinia reaction with a few papule rashes throughout his body that are mildly pruritic.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Blood pressure decreased, Erythema, Mental impairment, Pallor, Syncope
Clinical narrative: Following administration of Vaccines, patient experienced decreased BP (76/47), syncope, vomited x2 (clear bilious) and blanching of skin around eyes and to fingers of hands bilaterally. Cheeks and dorsal surface of hands became erythematous. Patient placed in supine position with LE raised. BP retaken 86/50 HR 90 O2 Sat=98% - no noted respiratory distress and lungs clear but mentation decreased, "dazed" appearance with blanching to periorbital area and fingers bilaterally, and erythema to cheeks and dorsal surface of hands remaining. BP retaken after lying supine for 10min - 92/47 but when taken to standing BP decreased to 76/48 HR 90 O2Sat=100%. Mentation remained decreased and "dazed" appearance persisted. 911 called after 40 minutes of efforts to stabilize unsuccessful - EPIPEN and Diphenhydramine administered. Dr. at ED called and report given. Transported to ER at ~1045hrs via EMS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Vomiting
Clinical narrative: Following administration of Vaccines, patient experienced decreased BP (76/47), syncope, vomited x2 (clear bilious) and blanching of skin around eyes and to fingers of hands bilaterally. Cheeks and dorsal surface of hands became erythematous. Patient placed in supine position with LE raised. BP retaken 86/50 HR 90 O2 Sat=98% - no noted respiratory distress and lungs clear but mentation decreased, "dazed" appearance with blanching to periorbital area and fingers bilaterally, and erythema to cheeks and dorsal surface of hands remaining. BP retaken after lying supine for 10min - 92/47 but when taken to standing BP decreased to 76/48 HR 90 O2Sat=100%. Mentation remained decreased and "dazed" appearance persisted. 911 called after 40 minutes of efforts to stabilize unsuccessful - EPIPEN and Diphenhydramine administered. Dr. at ED called and report given. Transported to ER at ~1045hrs via EMS.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Myalgia and redness, and swelling at injection site.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states the evening after the shot was given he experienced left arm swelling, blood red color down to his wrist, aching and pain in his arm. He did not seek medical attention but said he considered it. He used ice packs for 5 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Loss of personal independence in daily activities, Lumbar puncture, Muscle injury
Clinical narrative: All symptoms of Guillain-Barre' syndrome, had x-rays, MRI's, and  spinal tap , I have all medical records from beginning to end. Unable to function from this shot, muscles and severe nerve damage, I can barely walk, and do any normal day to day functions.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve injury, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: All symptoms of Guillain-Barre' syndrome, had x-rays, MRI's, and  spinal tap , I have all medical records from beginning to end. Unable to function from this shot, muscles and severe nerve damage, I can barely walk, and do any normal day to day functions.
Age: 53.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Pain, Wrong drug administered
Clinical narrative: On February 16, 2018 patient came in requesting MMR and Hepatitis B vaccines as he had chicken pox illness as child. Received Hepatitis B vaccine in left arm. MMRV vaccine given in right arm. Noted immediately after dose given. Informed client of error, reviewed and provided copy of VIS for MMRV and reviewed the side effects. Client was understanding of error saying "mistakes happen." Follow up phone call placed 2/20/2018 on patient's voice mail to check if concerns. Called again on 2/26/2018 and spoke with patient. He stated the only side effect was site being "a bit sore" but otherwise no adverse reaction.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal distension, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Pain in hand started on Friday then on Saturday was out of town and went to an urgent care there. He had hives, itching and swelling to L hand and abdomen.
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Pain, Skin warm
Clinical narrative: This is a spontaneous report form a contactable pharmacist received via Pfizer sales representative. A 73-year-old female patient received PREVNAR 13 intramuscular, in arm, on an unspecified date, at single dose, for immunization. Medical history was not reported. Concomitant vaccination included influenza vaccine, given on an unknown date, in a different arm, for immunization. On an unspecified date, after vaccination, the patient experienced pain, inflammation and hot area. Events outcome was unknown. Information on the batch number has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 19 month old male patient. The patient had no known concurrent conditions, medical history, drug reactions, allergies and concomitant medications. On an unknown date in July 2017, the patient was vaccinated with VARIVAX (dose, units, route and frequency not reported) (lot # M004335 and expiration date not reported) in the left thigh. On 30-JAN-2018, the patient experienced left flank shingles rash and patient was brought to the physician's office. The patient received unspecified treatment at the time of presenting to the physician's office. The outcome of the event herpes zoster was reported as recovered/resolved. The reporter did not provide causal relationship for the event herpes zoster with suspect therapy VARIVAX. No product quality complaint was involved. Lot number [M004335] is an invalid lot number for VARIVAX.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza, Pain, Pyrexia
Clinical narrative: A Health Professional (mother, Registered Nurse) report has been received concerning a 14 years 11 months old, Female patient with height: 69.0 Inches, weight: 117.0 Pounds. No information regarding the relevant history, concomitant disease and concomitant drug was provided. The patient was prescribed FLUMIST (intranasal) full dose in each nostril annually, start date 2009 or 2010 as prophylactic immunization. Mother reported that the patient had Type A flu during Nov-2016, went to Urgent care. The patient prescribed TAMIFLU adult dose twice a day and flu resolved. On Jan-2017 the patient contracted Type B flu, she went to Urgent care, patient's HCP aware, but no treatment provided and the patient had recovered. She reported that the patient missed doses of FLUMIST QUADRIVALENT for seasons 2016 to 2017 and 2017 to 2018. She took patient to Urgent Care on 18-Jan-2018 for fever 103.5 and the patient was diagnosed with Type A flu, she also had a cough and aches and pains. The patient was prescribed the following treatments: MOTRIN 400 mg by mouth every 6-8 hours for aches and pains start date 18-Jan-2018, TAMIFLU adult dose twice a day orally taken 19-Jan-2018 to 24-Jan-2018 and Hydrocodone cough syrup orally for cough prescribed twice a day, patient only took at night on 19-Jan-2018 and 20-Jan-2018, no doses provided. The patient was fever free on 21-Jan-2018 and mother reported that she was over the flu. The patient recovered from the events of multiple episodes of type A flu, type B flu and aches and pains on an unspecified date. Company physician assessed the events multiple episodes of type A flu, type B flu and aches and pains to be non-serious. Company physician suggested to delete the events of fever 103.5 and cough as these are symptoms for Influenza.
Age: 0.42
Sex: M
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age, Injection site pain, Irritability, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 5-month-old male patient received TRUMENBA (lot number: R94916, expiration date 30Jan2019), via an unspecified route of administration on 14Feb2018 at single dose for immunisation. Patient had no medical history. Concomitant medications included hepatitis b vaccine, rotavirus vaccine, and VITAMIN D. On 14Feb2018, it was reported that the instead of giving PREVNAR 13, the MA accidentally gave meningococcal group b rlp2086 to the patient. On 15Feb2018 10:00, the patient had low grade fever, also has sore leg at injection site and was a bit fussy. It was reported that the temperature was 101.8 and the patient was receiving acetaminophen. It was reported that the medication error was a result of PREVNAR 13 and TRUMENBA having exactly the same size box; explaining that both are white and green stripe on TRUMENBA was not very visible when stored in the fridge. It was also reported that the new training staff at that time was unfamiliar with the vaccine packaging. The reporter wanted to know what they should do and what type of adverse side effect there could be. Outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site haemorrhage
Clinical narrative: This is a spontaneous report from a contactable nurse (physician assistant). A patient of unspecified age, ethnicity and gender started to receive PREVNAR 13, (lot number: S70879, expiration date: Oct2019) via an unspecified route of administration on 19Feb2018 at 0.5 ml, single for routine vaccination. The patient's medical history included hemangioma from an unknown date. The patient's concomitant medications were not reported. On 19Feb2018, it was reported that one of the staff gave pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) but did not notice there was a hemangioma in the spot where the staff gave the injection. The reporter stated that injection site started to bleed and pressure was applied and the bleeding stopped. The reporter wanted to know if there are any side effects and what should they look for. The patient recovered from the injection site bleeding on an unspecified date.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced soreness in arm since the day she received the vaccine, date unspecified, until the time of the report. The reporter stated that they understand that soreness is not the common side effect of the vaccine but still wanted to know if this was okay or if there was a need to report further to the buyer. The outcome of the event was unknown. Information on the batch and lot numbers has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a contactable nurse (certified nurse practitioner, also the patient's daughter) via a Pfizer sales representative. A 94-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose as pneumococcal vaccine. It was stated that the dose was the regular standard dose that was always given. The patient's medical history, other medical conditions and concomitant medications were unknown. The nurse stated that her 94 year old mother received the vaccine and had a local reaction to the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) on an unspecified date. She did not know when this happened other than it was within the last 6 months. Outcome was reported as unknown however the nurse reported that she thinks the reaction all went away. Investigations were unknown. Information on batch and lot numbers has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported for a 94-year-old female patient (reporter's mother) that she received PREVNAR 13 (Lot Number and Expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for pneumocal vaccine. The patient medical history and concomitant medications were not reported. The patient received the vaccine and had redness and mostly local reaction on an unspecified date. She did not know when this happened other than it was within the last 6 months. The outcome of the event was unknown. Follow up has been requested for lot/ batch number.
Sex: U
Vaccine: PNC13
Symptoms: Platelet count decreased
Clinical narrative: This is a spontaneous report from a contactable Certified Nurse Practitioner via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date, within the last 6 months, at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a low platelet count (non serious) after receiving vaccine. The outcome of the event was unknown. The information on the batch/lot number has been requested.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the first of 3 reports. A patient of unspecified age ethnicity and gender received on the same unspecified day PREVNAR 13, at single dose and influenza vaccine both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot. The patient was sick after getting the flu shot plus pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date with outcome of unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018080774 same drug event different patients; US-PFIZER INC-2018080773 same drug event different patients.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the second of 3 reports. A patient of unspecified age, race, ethnicity and gender received on the same unspecified day PREVNAR 13, at single dose and influenza vaccine, both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot for immunization on an unspecified date. The patient was sick after getting the flu shot plus PREVNAR 13 on an unspecified date with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018080772 same suspect products, event, different patients; US-PFIZER INC-2018080774 same suspect products, event, different patients.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the third of 3 reports. A patient of unspecified age ethnicity and gender received on the same unspecified day PREVNAR 13, at single dose and influenza vaccine both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot for immunization. The patient was sick after getting the flu shot plus PREVNAR 13 on an unspecified date with outcome of unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018080773 same drug/ event, different patients; US-PFIZER INC-2018080772 same drug/ event, different patients.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy test positive, Blood test, Cough, Dry throat, Eye swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 20Feb2018 single dose for immunization. Medical history included aortic valve replacement from 2015 to an unknown date, food allergy ongoing, was a nonsmoker and was susceptible to bronchitis. The patient's concomitant medications were not reported. The patient woke with both eyes swollen on 21Feb2018 with outcome of not recovered, sore throat that feels like cotton on 21Feb2018 with outcome of not recovered, has been coughing a lot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test: allergy aspect was high on an unknown date. It was mentioned that the allergy aspect of the report from her blood work was high. Caller states she coughs a lot and has allergies. She went to her doctor for a checkup. She had blood work done. It was mentioned that the allergy aspect of the report from her blood work was high. She wanted to get the shot because she has been coughing a lot. She is a non-smoker and she is susceptible to bronchitis. Even now when she is talking, she can hear her voice break up a little bit because of that. Caller adds that she has a sore throat that feels like cotton in her throat. It is not horrible and she hates to even report it because it is off and on. She applied a clean warm cloth to her eyes, so they are not as uncomfortable as they were, but she thinks the swelling is about the same. Caller adds she had a shingles vaccine years ago when she was younger. No problems reported. She would like to know if there is any way there could have been eggs involved in the making of this product.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 20Feb2018 single dose for immunization. Medical history included aortic valve replacement from 2015 to an unknown date, food allergy ongoing, was a nonsmoker and was susceptible to bronchitis. The patient's concomitant medications were not reported. The patient woke with both eyes swollen on 21Feb2018 with outcome of not recovered, sore throat that feels like cotton on 21Feb2018 with outcome of not recovered, has been coughing a lot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test: allergy aspect was high on an unknown date. It was mentioned that the allergy aspect of the report from her blood work was high. Caller states she coughs a lot and has allergies. She went to her doctor for a checkup. She had blood work done. It was mentioned that the allergy aspect of the report from her blood work was high. She wanted to get the shot because she has been coughing a lot. She is a non-smoker and she is susceptible to bronchitis. Even now when she is talking, she can hear her voice break up a little bit because of that. Caller adds that she has a sore throat that feels like cotton in her throat. It is not horrible and she hates to even report it because it is off and on. She applied a clean warm cloth to her eyes, so they are not as uncomfortable as they were, but she thinks the swelling is about the same. Caller adds she had a shingles vaccine years ago when she was younger. No problems reported. She would like to know if there is any way there could have been eggs involved in the making of this product.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Hypoaesthesia, Influenza, Malaise, Nuclear magnetic resonance imaging brain
Clinical narrative: I immediately felt sick within an hour, had confusion later at night. Where friends asked if I was ok. My legs felt achy, symptoms like sciatica and trans ischemic attack, numbness in face, sick w/flu symptoms x 3 days then ended up w/major pain and sciatica diagnosed later (right leg to toes) and TIA.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Sciatica, Transient ischaemic attack
Clinical narrative: I immediately felt sick within an hour, had confusion later at night. Where friends asked if I was ok. My legs felt achy, symptoms like sciatica and trans ischemic attack, numbness in face, sick w/flu symptoms x 3 days then ended up w/major pain and sciatica diagnosed later (right leg to toes) and TIA.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Blood glucose normal, Blood pressure increased, Confusional state, Loss of consciousness
Clinical narrative: Had altered sensorium several minutes after having received ZOSTAVAX. He was tremulous and confused, but with stable Physical exam and vitals, but for markedly elevated BP in the 190's, normal glucose. He was packed for transport by EMS, where I accompanied him to the ER. Considerations would be a reaction to vaccination, hypertensive emergency w/altered sensorium. Per hospitalist note in ED. Confusion and acute loss of consciousness, tremors.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Had altered sensorium several minutes after having received ZOSTAVAX. He was tremulous and confused, but with stable Physical exam and vitals, but for markedly elevated BP in the 190's, normal glucose. He was packed for transport by EMS, where I accompanied him to the ER. Considerations would be a reaction to vaccination, hypertensive emergency w/altered sensorium. Per hospitalist note in ED. Confusion and acute loss of consciousness, tremors.