chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Electroencephalogram abnormal, Endotracheal intubation, Enterovirus test negative, Epstein-Barr virus test negative, Escherichia test negative
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Fatigue, Full blood count normal, General physical health deterioration, Grip strength decreased, Headache
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Hemiparesis, Herpes simplex test negative, Hypoxic-ischaemic encephalopathy, Immunoglobulin therapy, Influenza virus test negative
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Intensive care, Liver function test normal, Loss of personal independence in daily activities, Mental status changes, Metabolic function test normal
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Moaning, Monocytosis, Muscular weakness, Nervous system disorder, Neurological examination abnormal
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Oedema, Oxygen saturation decreased, Pharyngitis, Pleocytosis
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Pupil fixed, Scan with contrast abnormal, Specific gravity urine normal, Streptococcus test negative, Tachycardia
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Tremor, Unresponsive to stimuli, Urine ketone body present, Varicella virus test negative, Viral infection
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient's concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient's death (also reported as ''last Wednesday''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient's death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Unevaluable event
Clinical narrative: This a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation; and influenza vaccine, via an unspecified route of administration on an unspecified date at an unspecified dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the co-administration with flu vaccine had shown to cause decreased immune response to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. They inquired what was the required spacing to avoid this. Outcome of the events was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA), lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting on an unspecified date. Outcome of the event was unknown.  Information on lot number, batch number and expiration date has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 73-year-old female patient was administered a single dose of PREVNAR 13 in Aug2018, 6 days before this report, for immunization. Medical history and concomitant medications were not reported. The patient experienced a mild hive-like rash the evening of vaccine administration, which has gotten progressively more exaggerated over the course of the past few days. Outcome was not recovered.  Information on the batch number has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal distension, Abdominal pain, Arthralgia, Dyspnoea exertional, Fatigue
Clinical narrative: I had migratory polyarthralgia which has only significantly diminished more than one year later, I also had abdominal pain, bloating, and extreme fatigue and dyspnea on exertion.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Lethargy, Pain, Pyrexia
Clinical narrative: Fever, tiredness, lethargy, pain, generally feeling bad.
Age: 19.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthma, Hypersensitivity
Clinical narrative: Asthma and allergies.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscle rigidity, Seizure, Tremor
Clinical narrative: AFTER RECEIVING HIS VACCINE, PATIENT WENT HOME, ATE SUPPER AND WAS SITTING IN THE LIVINGROOM. MOM STATES SHE HEARD A THUD, TURNED AROUND, AND SAW HER SON LAYING ON HIS BACK SHAKING. PATIENT STOPPED SHAKING, BECAME RIGID, AND REMAINED RIGID FOR SEVERAL MORE MINUTES UNTIL EMS ARRIVED. PATIENT PROCEEDED TO ER FOR FURTHER EVALUATION. PATIENT WAS BACK AT BASELINE WITHIN 10 MINUTES OF START OF SEIZURE EPISODE. NO PRIOR HX OF SEIZURE ACTIVITY. FOLLOWING UP WITH NEUROLOGY.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: As reported by her physician: severe rash.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Pain in extremity
Clinical narrative: Approximately 2 hours after the injection, my arm went from feeling slightly sore to being extremely sore. The next morning I was feeling run down - temperature was 99.6. Temperature, shivering, and arm pain continued all day and overnight. Temperature reached 100.6 before finally returning to normal on second morning. Arm soreness still occurring as of second afternoon.
Age: 51.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Arthralgia, Burning sensation, Chills, Gait disturbance, Malaise
Clinical narrative: Fever,chills, burning sensation all over body, joint pains, trouble walking, malaise.
Age: 51.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever,chills, burning sensation all over body, joint pains, trouble walking, malaise.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Hypotension, Pallor, Shock, Syncope
Clinical narrative: Acute shock and syncope. Pale and diaphoretic, low BP. Resolved after about 10 min with lying flat with feet elevated.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event. Gave shot Intramuscular instead of giving the vaccine subcutaneous.
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 50 year old male patient, with no drug reactions or allergies. Information regarding the patient's pertinent medical history, concomitant and historical drugs was not provided. On 14-AUG-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # R005345 with expiration date of 01-MAR-2020, as vaccination (anatomical location was not privided). Then, on the same day, the patient reported having "chills and fatigue". It was reported that the patient did not seek medical attention, no laboratory diagnostics or treatment were performed, no intervention to prevent serious criteria was need, no disability was presented, no hospitalization was need and no life threatening event occurred. The pharmacist reported that the patient was recovering. The pharmacist requested a lot check and stated "it was time sensitive". The causality assessment between chills and fatigue with PNEUMOVAX 23 was not reported.; Sender's Comments: US-009507513-1808USA008021: US-009507513-1808USA007518:
Age: 0.33
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 4 months old patient (gender not reported), who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a four-month old patient received MENACTRA. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient who was vaccinated with 0.5 ml dose of MENACTRA (Lot number: U5848AA; expiry date: 11-Mar-2019) via intramuscular route in the right deltoid on 21-Jun-2018. The patient was also previously vaccinated with a dose of MENACTRA on 16-Oct-2017. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medications included GARDASIL for Immunisation. It was a case of actual medication error due to extra dose administered. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient called stating she had fever/chills, nausea & vomiting the evening of vaccine. Stated that she felt as though " she was going to die." She contacted her husband to bring her to the hospital, he came home and brought her "salt bread" and fluids, did not go to hospital. Stated to our RPh that she felt much better on the 25th.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Genital rash, Rash, Rash papular
Clinical narrative: Small red papules first appeared on neck and scalp, then spread to chest, back and genital area over next 2 days. Lesions on neck almost developed small central vesicle, but never truly became vesicular nor did they crust.  Over 50 papules were present. Patient did not seem febrile, and office visit showed normal temp. Patient slightly tired for 3-4 days. Totally recovered within one week.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Induration, Myalgia, Rash
Clinical narrative: Left upper extremity rash the day after injection with polyarthralgias that relieved with Tylenol at home the day after the injection. Fatigue and left upper extremity myalgia since vaccination. 1-2 cm indurated pustule noted on lateral aspect of left upper extremity, unknown if related to vaccination. No fever, chills, anaphylaxis, hives noted. All symptoms had resolved with the exception of left upper extremity muscle pain at time of office visit on 8/23/18.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: Left upper extremity rash the day after injection with polyarthralgias that relieved with Tylenol at home the day after the injection. Fatigue and left upper extremity myalgia since vaccination. 1-2 cm indurated pustule noted on lateral aspect of left upper extremity, unknown if related to vaccination. No fever, chills, anaphylaxis, hives noted. All symptoms had resolved with the exception of left upper extremity muscle pain at time of office visit on 8/23/18.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain of injection site that started 1 day after vaccine. Examined on 8/24/18 and was swollen about 15 cm diameter around the injection site.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Irritability
Clinical narrative: Fever to 102, nausea/vomiting, fussiness, papular rash on feet (now generalized), localized vesicular rash/induration/erythema/tenderness at injection site.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pyrexia, Rash generalised, Rash papular, Rash vesicular
Clinical narrative: Fever to 102, nausea/vomiting, fussiness, papular rash on feet (now generalized), localized vesicular rash/induration/erythema/tenderness at injection site.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Fever to 102, nausea/vomiting, fussiness, papular rash on feet (now generalized), localized vesicular rash/induration/erythema/tenderness at injection site.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Proquad given to 14 year old and only indicated until 13 years old.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Muscle aches (especially in back and legs), fever, chills, shaking, dizziness, loss of appetite, fatigue, red swollen injection area. Took TYLENOL for pain. Took shot on Wednesday. Symptoms began that night and resulted in only getting 3 hours of sleep. Thursday symptoms increased and by Friday symptoms were improved except for red swollen arm at the injection site.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: Muscle aches (especially in back and legs), fever, chills, shaking, dizziness, loss of appetite, fatigue, red swollen injection area. Took TYLENOL for pain. Took shot on Wednesday. Symptoms began that night and resulted in only getting 3 hours of sleep. Thursday symptoms increased and by Friday symptoms were improved except for red swollen arm at the injection site.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Muscle aches (especially in back and legs), fever, chills, shaking, dizziness, loss of appetite, fatigue, red swollen injection area. Took TYLENOL for pain. Took shot on Wednesday. Symptoms began that night and resulted in only getting 3 hours of sleep. Thursday symptoms increased and by Friday symptoms were improved except for red swollen arm at the injection site.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: The evening of the day I got the shot, at 9:00 pm I started having heavy chills and shaking. It came upon me like I had hit a brick wall. My temperature went to 102.5 F. Muscle aches, headache, miserable. I took 325 m TYLENOL that evening, then several times on the 22nd and 23rd. The fever ebbed up and down for 48 hours between 99F and 102F. As I type this up, it is the 25th. I no longer have a fever, however, I am still weak.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: The evening of the day I got the shot, at 9:00 pm I started having heavy chills and shaking. It came upon me like I had hit a brick wall. My temperature went to 102.5 F. Muscle aches, headache, miserable. I took 325 m TYLENOL that evening, then several times on the 22nd and 23rd. The fever ebbed up and down for 48 hours between 99F and 102F. As I type this up, it is the 25th. I no longer have a fever, however, I am still weak.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema, Blood test, Diarrhoea haemorrhagic
Clinical narrative: Went to pediatric ER for abdominal pain and bloody diarrhea on 08/19/2018.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Enema administration, Ultrasound abdomen
Clinical narrative: Went to pediatric ER for abdominal pain and bloody diarrhea on 08/19/2018.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Abdominal X-ray, Blood test, Enema administration, Intussusception, Laboratory test
Clinical narrative: Went to pediatric ER for abdominal pain and bloody diarrhea on 08/19/2018.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Ultrasound abdomen
Clinical narrative: Went to pediatric ER for abdominal pain and bloody diarrhea on 08/19/2018.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Induration, Injection site induration, Injection site swelling, Oedema peripheral
Clinical narrative: Mother reported that child has hard swelling of right deltoid that extends into axillary area. Mother denies any other symptoms. Advised mother to contact child's pediatrician Dr. for consultation.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Patient had redness and warmth of arm from shoulder to elbow. Also has a rash forming near the elbow. Advised BENADRYL, TYLENOL and cold compress.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, tenderness and swelling to left thigh.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Skin warm, Swelling, Vaccination site pain
Clinical narrative: The day of the vaccine and the day after, he suffered a lot of pain in his arm where the injection was given. The day after the vaccine, he developed a hard, swollen, red area that was hot to the touch. The red area spread a great deal over his upper arm for the next 2 days. By the 3rd day after the vaccine, it began to decrease in color and size. There was no longer any pain.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Muscle aches, shivering, ongoing at this time.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Frequent bowel movements, Pyrexia
Clinical narrative: Infant developed fever and loose watery stools on 8/16/2018, 2 days after vaccine. Fever only one day but Diarrhea persisted for a week with up to 12 stools per day. No blood in stool. No emesis. Diaper rash developed due to diarrhea. Mother states older sibling of this infant died from intussuception.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Intussusception, reduced with air enema.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Pt. presented with tiny vesicles center chest 4 days after SHINGRIX #2.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Herpes zoster, Injection site pustule, Injection site rash, Injection site scab
Clinical narrative: Within a day or 2 I broke out in a rash on left upper arm. Some scabs formed some had pus.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: By 7:30 that same evening I had the chills which lasted until 12:30 AM. I would fall asleep and wake up with chills - shivering couldn't stop. Took 2 Extra Strength TYLENOL. Spoke with doctor next day.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Within one hour of vaccine - patient had severe headache (worst of life), nausea, chills, muscle aches. 20 YO M presents to ED S/P meningitis vaccine at about 11:30 this morning for C/O chills, nausea, one episode of violent vomiting, and headache about an hour after the vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abscess, Cellulitis
Clinical narrative: Patient required medical treatment for post vaccination diagnosis of cellulitis with an abscess on the left arm.  Patient was hospitalized for antibiotic treatment.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was 19 y/o at the time, given adult dose when she should have received a peds dose. No reaction, pt tolerated well. This was d/t human error and should have been prevented, yet with the dosage for Hep B peds up to and including 19 year olds and Hep A up to and including 18 years old, it seems this was an error waiting to happen. The information (dosage age) should AT LEAST be written on the outside of the vaccine box.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode, in exam room, after all vaccines were administered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Malaise
Clinical narrative: Painful, reddened and hard at injection site. Fever 102.3, chills, aches. General not feeling well.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Painful, reddened and hard at injection site. Fever 102.3, chills, aches. General not feeling well.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Several hours after vaccination, pt experienced pain at site and to entire upper left arm that kept her up. Patient came into clinic next day for assessment, site was warm to the touch with swelling and slight redness covering 90 % of her upper outer left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site vesicles
Clinical narrative: 10 cm by 12 cm erythematous area on the right thigh where the vaccines were given with some an indurated area and cluster of small vesicles, started 2 days after shots were given and has continued to expand 2 days later.
Age: 13.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: ADMINISTERED TDAP AND HEPATITIS A INTO LEFT DELTOID. IMMEDIATELY AFTER ADMINISTRATION, WHILE HOLDING COTTON BALLS TO TDAP INJECTION SITE DUE TO BLEEDING, CLIENT STATED HE FELT DIZZY. COLD PACK APPLIED TO BACK OF NECK. DIZZINESS CONTINUED AFTER APPROXIMATELY ONE MINUTE. ASSISTED CLIENT TO COT, PLACED IN SUPINE POSITION WITH LEGS ELEVATED. STATED HE FELT BETTER AFTER LYING DOWN. DENIED NAUSEA SO GIVEN JUICE TO SIP ON. AFTER APPROXIMATELY 5 MINUTES, ADMINISTERED HPV (GARDASIL-9) AND MCV4 (MENACTRA) WITH CLIENT IN SUPINE POSITION, WITHOUT INCIDENT. AFTER APPROXIMATELY 5 MINUTES, ASSISTED CLIENT TO SIT UP ON SIDE OF COT. DENIED DIZZINESS. ASSISTED TO WALK APPROXIMATELY 4  FEET TO CHAIR CONTINUED TO DENY DIZZINESS. AFTER SITTING IN CHAIR APPROXIMATELY 3 MINUTES WITHOUT INCIDENT, CLIENT LEFT IN CARE OF GRANDMOTHER.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness/swelling/pain in the upper left arm. She said it never worsened or spread, but did last for 7 days. Patient never had a fever or systemic symptoms.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Muscle contractions involuntary, Nausea, Pallor, Posture abnormal
Clinical narrative: Client sat on exam table for vaccination then sat on MOC lap after vaccines administered. This provider vaccinated sibling while patient sat in mother's lap. Minutes later, client stated felt nauseous but declined drink of water/H2O. Client stood and splashed water on face and walked around room. Client developed pallor and became diaphoretic when leaned back into FOC lap and eased to ground. When asked if okay - client nodded head up and down then had legs extended out and right hand with clenched fist and bent elbow. Safety of child ensured - was eased to ground without difficulty or injury. Cool compress to forehead and air fanned toward client. Parents reassured. Juice provided to client. Instruction to F/U with provider. Business card given to MOC in case PCP has any questions or concerns. Supervisor notified.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Mixed with sterile diluent instead of diluent that came with vaccine.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness, Hypoacusis, Vision blurred
Clinical narrative: ADMINISTERED MENACTRA, TRUMENBA, GARDASIL 9, AND HAVRIX VACCINES. APPROXIMATELY 5 MINUTES AFTER ADMINISTRATION, CLIENT STATED SHE FELT DIZZY WITH BLURRED VISION AND DIFFICULTY HEARING. DENIED NAUSEA. GIVEN SOME JUICE TO SIP ON AND COOL PACK APPLIED TO BACK OF NECK. CONTINUED TO COMPLAIN OF DIZZINESS. ASSISTED TO COT AND PLACED IN SUPINE POSITION WITH KNEES ELEVATED AFTER APPROXIMATELY 5 MINUTES, STATED SHE FELT BETTER AND DIZZINESS WAS IMPROVED. ASSISTED TO SIT ON SIDE OF COT FOR APPROXIMATELY 1 TO 2 MINUTES, THEN ASSISTED TO SIT IN CHAIR. AFTER APPROXIMATELY 2 TO 3 MINUTES, ASSISTED TO WAITING ROOM. WAITED WITH DAD FOR APPROXIMATELY 5 MORE MINUTES WITHOUT FURTHER INCIDENT. LEFT IN CARE OF FATHER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe muscle pain, severe joint pain, extremely hot skin, chills, headache, severe fatigue, loss of appetite. Could not go to work the following day. It crossed my mind to go to the ER but I knew I was not actually sick, I just felt like I had the worst flu ever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Myalgia, Skin warm
Clinical narrative: Severe muscle pain, severe joint pain, extremely hot skin, chills, headache, severe fatigue, loss of appetite. Could not go to work the following day. It crossed my mind to go to the ER but I knew I was not actually sick, I just felt like I had the worst flu ever.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client was being seen for Well Child Med Home Visit at Dr office. 15 minutes after receiving vaccine, client experienced "burning" at injection sites. Exam noted mild swelling and redness just around band aids over injection site on both sites. Redness and mild swelling expanded to approximately 8 cm over period of 5 minutes. Client denied any other discomfort or symptoms during event. Benadryl 25 mg Im administered at 11:00. Signs and symptoms of reaction alleviated in 20 minutes. Client was discharged to Mother s care at 11:40 in stable condition without s/s of redness or swelling at affected sites.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area to left upper arm red and warm to touch. 4 inches in diameter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Skin ulcer
Clinical narrative: Patient experienced sores on head. Mildly painful, slightly itchy. Patient went in a few days after noticing this. Doctor diagnosed sores as a mild form of shingles.
Age: 23.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Abdominal pain lower, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, pain, and swelling at the site of injection to left deltoid muscle, warm to the touch. Reports intermittent lower abdominal pain.
Age: 82.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Skin infection, Skin ulcer, Wound treatment
Clinical narrative: Patient claims pain in left arm (FLUZONE HD) after injection and days following injection (vaccine on 08/08/2019). Pain was not resolving. Patient had a follow up check up appointment with primary care doctor on 08/21/19 and arm was examined and was referred to ER. Patient went to Hospital ER same day where skin was diagnosed with infection and ulcer. Ulcer was cleaned out and packaged and is getting regularly cleaned by hospital. Patient's other injection (SHINGRIX) reports no adverse events.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: After receiving the PNEUMOVAX 23 vaccine on 8/22/18, a few hours after she received it around 1400, the injection site to her left deltoid swelled to the size of a tennis ball and she had soreness to the site. She denies any numbness or tingling down arm, denies fever, discoloration, or any other symptoms. She was told by a friend who is a doctor to take benadryl and she said today (8/24/18) the swelling has gone down a lot, but she still has soreness to the site. Patient is currently away from home.
Age: 8.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Wrong patient received product
Clinical narrative: No signs or symptoms present. Medical Assistant asked patients mother to confirm name of patient and mother agreed. Medical Assistant administered shots to patient and when a different patient with the same name required shots at the same time, medical assistant noticed the wrong two shots were given to the patient.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Musculoskeletal stiffness, Myalgia
Clinical narrative: Pt started feeling some pain in the left arm radiating bilaterally till the wrist, felt some numbness and burning sensation. Went to the Dr, told her that she shouldn't have gotten it that day as the pt was having muscle stiffness and tenderness, gave the pt some ibuprofen, told it might go away in few days till 3 months.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt started feeling some pain in the left arm radiating bilaterally till the wrist, felt some numbness and burning sensation. Went to the Dr, told her that she shouldn't have gotten it that day as the pt was having muscle stiffness and tenderness, gave the pt some ibuprofen, told it might go away in few days till 3 months.
Age: 0.25
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Patient received MMR, Varicella, and Hep A vaccines wrongfully.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient was unable to move arm within three to four hours after administration. She starting having pain radiating from fingers to neck. The emergency room doctor concluded that the immunization may have been given too far up on the arm, as he told the patient's family that it was 1.5 finger widths below the shoulder.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Local reaction, Vaccination complication
Clinical narrative: Per Dr.'s office visit notes 8/24/18-"Adverse reaction to bacterial vaccines - Patient appears to have had a local reaction to the pneumococcal vaccination. It is erythematous and slightly warm to the touch. I am going to start the patient on a medrol dose pack to help with inflammation and erythema. In case this is a cellulitis I am going to start her on a low dose of bactrim for the next 5 days."
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash and itchiness started about 3 hours after administration.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Headache, Injection site rash, Injection site swelling, Mobility decreased
Clinical narrative: Severe arm pain later in the day after injection. Was unable to sit up or walk around. The next day, severe pain spread to other arm and neck and back with a headache and fever. The injection site was swollen and a rash was present for about 4 days.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain later in the day after injection. Was unable to sit up or walk around. The next day, severe pain spread to other arm and neck and back with a headache and fever. The injection site was swollen and a rash was present for about 4 days.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial flutter, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: Daily pulse reading on the days following the injection have been between 149 and 160, whereas long established baseline pulse readings for years have been in the 80 to 90 range.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient came in wearing an arm sling saying she is in pain and cannot move or lift her left arm.  She went to the hospital due to the severe pain where she was given MOTRIN and was instructed to ice the arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient complained of swollen underarm, redness and pain. Recommended patient BENADRYL and to go see urgent care. We have tried to contact patient to find out MD and outcome, but no answer several times.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: SYNCOPY.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus in Left ear- started about a week after initial vaccine of SHINGRIX, started seeing Chiropractor 1 month after tinnitus began.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site mass
Clinical narrative: Pt had a red inflamed area around injection site with a hard lump under the skin -- pt reported to pharmacy 14 days after receiving the vaccine.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass
Clinical narrative: After injecting the vaccine by 2 minutes while I was monitoring the patient, I noticed a small, hard lump at the injection site. The patient said he doesn't feel any pain and while monitoring the patient, I noticed it was getting smaller. Kept monitoring the patient for 20 minutes and he said he is feeling well and he doesn't have any pain or discomfort at the injection site and left.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient stated 3 fingers of her right hand and right leg are numb since the shot was given. Advised patient to see a doctor about the adverse reaction and followup with us after the appointment.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Patient had a headache, flu-like symptoms, achiness, redness/warmth around injection site approximately 2 inches in diameter starting day after vaccination. 2 days post vaccination she doesn't have the headache or flu-like symptoms anymore but the redness/warmth around the injection site is still there. Recommended to ice the area.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Pyrexia, Skin tightness
Clinical narrative: Patient states that left arm swollen and that he had a fever after pneumococcal vaccine. Patient states that it felt like he had a tight rubber band around the right arm. States his arm was really hard like metal and painful. Patient states that he had to take tylenol for fever, which did not return after he took the tylenol. Swelling lasted 2-3 days and the pain lasted a few more days than the swelling. Patient states that his arm is back to normal now without any lasting effect. Image attached to e-mail.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Patient states a few days after getting vaccine her arm became red and she could fill a hard spot at injection site. States she also had a headache/fever. Came to pharmacy today ( over 1 week later) arm has some red spots near injection site & she states it itches. Said that it  is not as itchy as it was and redness not as bad. Told her to take Benadryl and call MD if it gets worse/does not improve after taking benadryl.