chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Aggression, Autism spectrum disorder, Blood culture, Culture urine, Developmental delay
Clinical narrative: Ear Infections, Not Feeding, Vomiting, Fussy, Fever, Not Sleeping, Self Injurious, Hurting others, PICA, Fluid Behind ears, Vesicoureteral Reflux ( VUR ), GERD,  Autism, ENCEPHALOPATHY, Cannot tolerate Lactose, Cannot tolerate phenol foods like Almonds, Very Hyperactive, Developmental stage of a 1 yr old child, Cannot do any self care, Needs 24 hour care.
Sex: M
Vaccine: HEP
Symptoms: Ear infection, Encephalopathy, Escherichia infection, Escherichia test positive, Feeding disorder
Clinical narrative: Ear Infections, Not Feeding, Vomiting, Fussy, Fever, Not Sleeping, Self Injurious, Hurting others, PICA, Fluid Behind ears, Vesicoureteral Reflux ( VUR ), GERD,  Autism, ENCEPHALOPATHY, Cannot tolerate Lactose, Cannot tolerate phenol foods like Almonds, Very Hyperactive, Developmental stage of a 1 yr old child, Cannot do any self care, Needs 24 hour care.
Sex: M
Vaccine: HEP
Symptoms: Food intolerance, Gastrooesophageal reflux disease, Insomnia, Intentional self-injury, Irritability
Clinical narrative: Ear Infections, Not Feeding, Vomiting, Fussy, Fever, Not Sleeping, Self Injurious, Hurting others, PICA, Fluid Behind ears, Vesicoureteral Reflux ( VUR ), GERD,  Autism, ENCEPHALOPATHY, Cannot tolerate Lactose, Cannot tolerate phenol foods like Almonds, Very Hyperactive, Developmental stage of a 1 yr old child, Cannot do any self care, Needs 24 hour care.
Sex: M
Vaccine: HEP
Symptoms: Lactose intolerance, Loss of personal independence in daily activities, Middle ear effusion, Pica, Psychomotor hyperactivity
Clinical narrative: Ear Infections, Not Feeding, Vomiting, Fussy, Fever, Not Sleeping, Self Injurious, Hurting others, PICA, Fluid Behind ears, Vesicoureteral Reflux ( VUR ), GERD,  Autism, ENCEPHALOPATHY, Cannot tolerate Lactose, Cannot tolerate phenol foods like Almonds, Very Hyperactive, Developmental stage of a 1 yr old child, Cannot do any self care, Needs 24 hour care.
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Urinary tract infection, Vesicoureteric reflux, Vomiting
Clinical narrative: Ear Infections, Not Feeding, Vomiting, Fussy, Fever, Not Sleeping, Self Injurious, Hurting others, PICA, Fluid Behind ears, Vesicoureteral Reflux ( VUR ), GERD,  Autism, ENCEPHALOPATHY, Cannot tolerate Lactose, Cannot tolerate phenol foods like Almonds, Very Hyperactive, Developmental stage of a 1 yr old child, Cannot do any self care, Needs 24 hour care.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Noted small red healed area on left lateral thigh approx. size small eraser. No noted signs of severe distress. Child alert playful walking on legs with no trouble. Parents understand need to follow up with Pvt. MD or ER if any other problems occur. Parent given my business card.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle fatigue, Muscular weakness, Paraesthesia
Clinical narrative: Muscle fatigue, weakness and tingling in both legs.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Received a ZOSTAVAX vaccination at his pharmacy. In less than 24 hours he developed a painful blistery rash which I diagnosed as herpes zoster.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Tdap and MENACTRA given on L arm by medical assistant 03/13/2017. Patient came into office 03/15/17 c/o swollen L arm. Itchy and erythematous. Diagnosed w cellulitis and prescribed KEFLEX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm, Tenderness, Urticaria
Clinical narrative: Morning after vaccine, patient noticed raised welt like rash approximately 8" x 4" and reports that it is hot to the touch, painful to touch, but otherwise aches in a minor way. Patient directed to contact PCP on 4/24/17, monitor for improvement/progression. Treat with ice and IBU.
Age: 1.83
Sex: M
Vaccine: HEPA
Symptoms: Chest X-ray, Differential white blood cell count, Full blood count, Generalised tonic-clonic seizure, Metabolic function test
Clinical narrative: Generalized tonic clonic seizure lasting less than 5 min. No measured fever during or after the event. This happened once the afternoon of the day after his immunization. He was taken by ambulance to the emergency room after the event at 1428 on 4/13
Age: 1.83
Sex: M
Vaccine: HEPA
Symptoms: Urine analysis
Clinical narrative: Generalized tonic clonic seizure lasting less than 5 min. No measured fever during or after the event. This happened once the afternoon of the day after his immunization. He was taken by ambulance to the emergency room after the event at 1428 on 4/13
Age: 24.0
Sex: U
Vaccine: MMR
Symptoms: Dysgeusia, Lymphadenopathy, Pyrexia
Clinical narrative: Pt. reported 2-3 days after shot swollen glands/fever would come and go. Poor taste/denied swelling of face/no hives, no difficulty breathing, no dizziness or weakness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal faeces, Faeces discoloured
Clinical narrative: Mother of child states that after immunizations on 2/20/17 child's feces was green, frothy and foul smelling for a week.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Injection site reactions, discoloration and swelling, no pain, per patient onset 5 to 6 hours after.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture stool negative, Faeces discoloured, Haematochezia, Laboratory test, Mucous stools
Clinical narrative: Rash around mouth 4/11/17, green, mucous stools started on 4/9/17, positive for blood on 4/12/17. Has continued with symptoms even with mom switching to a non-dairy and soy diet.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Occult blood positive, Oral mucosal eruption, Rotavirus test negative, White blood cells stool
Clinical narrative: Rash around mouth 4/11/17, green, mucous stools started on 4/9/17, positive for blood on 4/12/17. Has continued with symptoms even with mom switching to a non-dairy and soy diet.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Indurated rash at site of injection Tx with BENADRYL.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Swelling, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (627552) under the Freedom of Information Act, referring to a 12 year old male patient. The patient did not have medical history or concurrent conditions. On 09-MAR-2016, the patient was vaccinated in his left arm with the second dose of GARDASIL 9 lot # L018351 (strength, route and expiration date were unknown) for prophylaxis. Concomitant therapies included multivitamin with fluoride. On 13-MAR-2016, reported as 5 days later after vaccination, the patient experienced swelling and tenderness. At the time of the report, the outcome of swelling and tenderness was reported as not recovered. The reporter did not assess the relatedness between swelling and tenderness and GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (627552) under the Freedom of Information Act, referring to a 12 year old male patient. The patient did not have medical history or concurrent conditions. On 09-MAR-2016, the patient was vaccinated in his left arm with the second dose of GARDASIL 9 lot # L018351 (strength, route and expiration date were unknown) for prophylaxis. Concomitant therapies included multivitamin with fluoride. On 13-MAR-2016, reported as 5 days later after vaccination, the patient experienced swelling and tenderness. At the time of the report, the outcome of swelling and tenderness was reported as not recovered. The reporter did not assess the relatedness between swelling and tenderness and GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Hyperacusis, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (627552) under the Freedom of Information Act, referring to a 12 year old male patient. The patient did not have medical history or concurrent conditions. On 09-MAR-2016, the patient was vaccinated in his left arm with the second dose of GARDASIL 9 lot # L018351 (strength, route and expiration date were unknown) for prophylaxis. Concomitant therapies included multivitamin with fluoride. On 13-MAR-2016, reported as 5 days later after vaccination, the patient experienced swelling and tenderness. At the time of the report, the outcome of swelling and tenderness was reported as not recovered. The reporter did not assess the relatedness between swelling and tenderness and GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dizziness
Clinical narrative: This spontaneous report refers to an 11 year old female patient. The patient's current condition included pharyngitis streptococcal.  Past medical history and concomitant medications were not provided. On 13-MAY-2016, the patient was vaccinated with GARDASIL 9 in the left arm (lot # M003659, expiry date, route unknown), ADACEL in the right arm (lot # UI565AA, expiry date, route unknown) and MENACTRA in the left arm (lot # U5216AA, expiry date, route unknown) for prophylaxis. The vaccines were administered at private doctor's office or hospital. On the same day (13-MAY-2016), the patient experienced chest pain and dizziness. On an unknown date the patient was hospitalized for the events. The outcome of the events was reported as recovered. Causality assessment was not provided. The agency considered the events to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Imaging procedure, Lumbar puncture abnormal, Scan abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 11 year old female patient. The patient's historical condition included weight loss, depression and anxiety. On 03-MAY-2016, the patient was vaccinated with GARDASIL 9 from lot # L026602 (exp. date not provided) dose 1, intramuscular.  On 17-MAY-2016, the patient experienced electromyogram abnormal, scan abnormal, lumbar puncture abnormal, imaging procedure and Guillain-Barre syndrome. On an unknown date, the patient was hospitalized. The outcome of the events was reported as recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information is not expected, because no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Electromyogram abnormal, Immunoglobulin therapy, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Information was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI), AGENCY#636995) regarding a 14 years old male patient (reported as 14 units unknown). The patient's concurrent conditions included acne vulgaris. The patient's other medications included VYVANSE (manufacturer unknown) 30 mg daily. On 29-DEC-2015 (also reported as 2016), the patient was vaccinated with GARDASIL 9 lot # L014415, (strength, dose and expiry date not reported) at a dose number 2 intramuscularly in the left arm (non-dominant shoulder) for prophylaxis. The patient experienced pain shortly after receiving his HPV vaccine. The patient experienced pain at the injection site which was more periscapular and in the area of the upper trapezius. His arm felt very weak now, he had a hard time forward flexing or abducting the shoulder. The patient had been swimming competitively for senior high school and was unable to do so due to the pain and weakness. His pain did not radiate and he did not think his grip had been affected. He had more pain sometimes at night and woke up that morning with pain and he thought he might have slept on his left side, which was not usual for him. He had no numbness or tingling. He had no swelling. He had no history of similar symptoms. He had no history of trauma to the shoulder that he could recall. The patient was diagnosed with Parsonage-Turner Syndrome by Musculoskeletal Specialist, the patient was referred to Neurology. Diagnosis was confirmed by EMG as (neuralgic amyopathy). The Patient was admitted to the hospital and received two rounds of IVIG on 07-MAR-2016. Patient continued to have slightly diminished muscle bulk of the left shoulder compared to the right. At most recent evaluation on 28-MAR-2016, he continued to have mild scapular winging when doing a wall pushup and had mild scapular dyskinesia with slow controlled shoulder abduction. Full-strength with resisted internal and external rotation and supraspinatus testing, sub capsular slipped off test, shoulder flexion and abduction. They were biceps and triceps strength. The outcome of the events were reported as not recovered at the time of this report. Additional information is not expected as the case was received from regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Mobility decreased, Muscle atrophy, Muscular weakness, Neuralgic amyotrophy, Pain
Clinical narrative: Information was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI), AGENCY#636995) regarding a 14 years old male patient (reported as 14 units unknown). The patient's concurrent conditions included acne vulgaris. The patient's other medications included VYVANSE (manufacturer unknown) 30 mg daily. On 29-DEC-2015 (also reported as 2016), the patient was vaccinated with GARDASIL 9 lot # L014415, (strength, dose and expiry date not reported) at a dose number 2 intramuscularly in the left arm (non-dominant shoulder) for prophylaxis. The patient experienced pain shortly after receiving his HPV vaccine. The patient experienced pain at the injection site which was more periscapular and in the area of the upper trapezius. His arm felt very weak now, he had a hard time forward flexing or abducting the shoulder. The patient had been swimming competitively for senior high school and was unable to do so due to the pain and weakness. His pain did not radiate and he did not think his grip had been affected. He had more pain sometimes at night and woke up that morning with pain and he thought he might have slept on his left side, which was not usual for him. He had no numbness or tingling. He had no swelling. He had no history of similar symptoms. He had no history of trauma to the shoulder that he could recall. The patient was diagnosed with Parsonage-Turner Syndrome by Musculoskeletal Specialist, the patient was referred to Neurology. Diagnosis was confirmed by EMG as (neuralgic amyopathy). The Patient was admitted to the hospital and received two rounds of IVIG on 07-MAR-2016. Patient continued to have slightly diminished muscle bulk of the left shoulder compared to the right. At most recent evaluation on 28-MAR-2016, he continued to have mild scapular winging when doing a wall pushup and had mild scapular dyskinesia with slow controlled shoulder abduction. Full-strength with resisted internal and external rotation and supraspinatus testing, sub capsular slipped off test, shoulder flexion and abduction. They were biceps and triceps strength. The outcome of the events were reported as not recovered at the time of this report. Additional information is not expected as the case was received from regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Radiculitis brachial, Winged scapula
Clinical narrative: Information was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI), AGENCY#636995) regarding a 14 years old male patient (reported as 14 units unknown). The patient's concurrent conditions included acne vulgaris. The patient's other medications included VYVANSE (manufacturer unknown) 30 mg daily. On 29-DEC-2015 (also reported as 2016), the patient was vaccinated with GARDASIL 9 lot # L014415, (strength, dose and expiry date not reported) at a dose number 2 intramuscularly in the left arm (non-dominant shoulder) for prophylaxis. The patient experienced pain shortly after receiving his HPV vaccine. The patient experienced pain at the injection site which was more periscapular and in the area of the upper trapezius. His arm felt very weak now, he had a hard time forward flexing or abducting the shoulder. The patient had been swimming competitively for senior high school and was unable to do so due to the pain and weakness. His pain did not radiate and he did not think his grip had been affected. He had more pain sometimes at night and woke up that morning with pain and he thought he might have slept on his left side, which was not usual for him. He had no numbness or tingling. He had no swelling. He had no history of similar symptoms. He had no history of trauma to the shoulder that he could recall. The patient was diagnosed with Parsonage-Turner Syndrome by Musculoskeletal Specialist, the patient was referred to Neurology. Diagnosis was confirmed by EMG as (neuralgic amyopathy). The Patient was admitted to the hospital and received two rounds of IVIG on 07-MAR-2016. Patient continued to have slightly diminished muscle bulk of the left shoulder compared to the right. At most recent evaluation on 28-MAR-2016, he continued to have mild scapular winging when doing a wall pushup and had mild scapular dyskinesia with slow controlled shoulder abduction. Full-strength with resisted internal and external rotation and supraspinatus testing, sub capsular slipped off test, shoulder flexion and abduction. They were biceps and triceps strength. The outcome of the events were reported as not recovered at the time of this report. Additional information is not expected as the case was received from regulatory authority.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Arthralgia, Blood test, Computerised tomogram abdomen, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 13 year old female patient. Her concurrent condition included acne. The patient was also reported to be very healthy prior to vaccination. Her medical history included eczema. On 04-NOV-2014, the patient was vaccinated with GARDASIL 9 (first vaccination, lot# K009482) (expiration date and route unknown) for prophylaxis. Concomitant therapies included KEFLEX. On 23-JAN-2015, the patient received second dose vaccination with GARDASIL 9 (lot# K008931) (expiration date and route unknown) for prophylaxis. On 25-JAN-2015, after the second vaccination, the patient experienced abdominal pain (life threatening), pain (life threatening), arthralgia (life threatening), occipital neuralgia (life threatening), menstruation irregular (life threatening), hypothyroidism (life threatening), myalgia (life threatening), blood test (life threatening), computerised tomogram (life threatening), nuclear magnetic resonance imaging brain (life threatening) and ultrasound abdomen (life threatening). The patient required emergency room visit for the events. The patient received MOTRIN as treatment for the chronic headaches. The patient underwent numerous blood tests, computerised tomogram (CT) scan of abdomen, nuclear magnetic resonance imaging (MRI) of brain and ultrasound abdomen for which the results were unknown. On 26-MAY-2015, the patient received third dose vaccination with GARDASIL 9 (lot# K023432, in arm) (expiration date and route unknown) for prophylaxis. On 01-JUN-2015, the patient was hospitalized after third vaccination for all the events. The outcome of all events was reported as not recovered/not resolved. The causality of all events was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
Sex: F
Vaccine: HPV9
Symptoms: Hypothyroidism, Menstruation irregular, Myalgia, Nuclear magnetic resonance imaging brain, Occipital neuralgia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 13 year old female patient. Her concurrent condition included acne. The patient was also reported to be very healthy prior to vaccination. Her medical history included eczema. On 04-NOV-2014, the patient was vaccinated with GARDASIL 9 (first vaccination, lot# K009482) (expiration date and route unknown) for prophylaxis. Concomitant therapies included KEFLEX. On 23-JAN-2015, the patient received second dose vaccination with GARDASIL 9 (lot# K008931) (expiration date and route unknown) for prophylaxis. On 25-JAN-2015, after the second vaccination, the patient experienced abdominal pain (life threatening), pain (life threatening), arthralgia (life threatening), occipital neuralgia (life threatening), menstruation irregular (life threatening), hypothyroidism (life threatening), myalgia (life threatening), blood test (life threatening), computerised tomogram (life threatening), nuclear magnetic resonance imaging brain (life threatening) and ultrasound abdomen (life threatening). The patient required emergency room visit for the events. The patient received MOTRIN as treatment for the chronic headaches. The patient underwent numerous blood tests, computerised tomogram (CT) scan of abdomen, nuclear magnetic resonance imaging (MRI) of brain and ultrasound abdomen for which the results were unknown. On 26-MAY-2015, the patient received third dose vaccination with GARDASIL 9 (lot# K023432, in arm) (expiration date and route unknown) for prophylaxis. On 01-JUN-2015, the patient was hospitalized after third vaccination for all the events. The outcome of all events was reported as not recovered/not resolved. The causality of all events was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
Sex: F
Vaccine: HPV9
Symptoms: Pain, Ultrasound abdomen
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 13 year old female patient. Her concurrent condition included acne. The patient was also reported to be very healthy prior to vaccination. Her medical history included eczema. On 04-NOV-2014, the patient was vaccinated with GARDASIL 9 (first vaccination, lot# K009482) (expiration date and route unknown) for prophylaxis. Concomitant therapies included KEFLEX. On 23-JAN-2015, the patient received second dose vaccination with GARDASIL 9 (lot# K008931) (expiration date and route unknown) for prophylaxis. On 25-JAN-2015, after the second vaccination, the patient experienced abdominal pain (life threatening), pain (life threatening), arthralgia (life threatening), occipital neuralgia (life threatening), menstruation irregular (life threatening), hypothyroidism (life threatening), myalgia (life threatening), blood test (life threatening), computerised tomogram (life threatening), nuclear magnetic resonance imaging brain (life threatening) and ultrasound abdomen (life threatening). The patient required emergency room visit for the events. The patient received MOTRIN as treatment for the chronic headaches. The patient underwent numerous blood tests, computerised tomogram (CT) scan of abdomen, nuclear magnetic resonance imaging (MRI) of brain and ultrasound abdomen for which the results were unknown. On 26-MAY-2015, the patient received third dose vaccination with GARDASIL 9 (lot# K023432, in arm) (expiration date and route unknown) for prophylaxis. On 01-JUN-2015, the patient was hospitalized after third vaccination for all the events. The outcome of all events was reported as not recovered/not resolved. The causality of all events was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Concussion, Fall, Laceration, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 17 year old male patient. The patient's past medical history included asthma and attention deficit/hyperactivity disorder (ADHD). The patient had received prior vaccinations. There were no current illness. On 10-JUN-2016, the patient was vaccinated with GARDASIL 9, dose number 1, (dose unknown) intramuscularly in the right arm from lot # M003659 for prophylaxis. Other suspect therapies included MENACTRA, dose number 2 (dose unknown), administered intramuscularly in the right arm from lot# U5180AA on 10-JUN-2016 for prophylaxis. The patient was also taking dexmethylphenidate hydrochloride (FOCALIN). On 10-JUN-2016, the patient experienced syncope episode after receiving vaccination with GARDASIL 9 and MENACTRA. The patient had laceration to scalp and concussion due to fall. Emergency medical services (EMS) transported the patient to emergency department (ED) where patient was admitted overnight (Hospitalized). The outcome of laceration, concussion, fall and syncope was reported as recovered (event stop date: unknown date in June 2016). Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Day after vaccines patient had a febrile seizure; seen in ER and D/C'd. F/U visit in clinic child was doing well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Nausea, Somnolence, Vomiting, Wheezing
Clinical narrative: Anaphylaxis after receiving MMRV+IPV+DTaP. Had received all before. Started with nausea, emesis, became diaphoretic and hypoxic to 87% SaO2. Developed wheezing and angioedema.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Angioedema, Hyperhidrosis, Hypoxia, Nausea
Clinical narrative: Anaphylaxis after receiving MMRV+IPV+DTaP. Had received all before. Started with nausea, emesis, became diaphoretic and hypoxic to 87% SaO2. Developed wheezing and angioedema.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Vomiting, Wheezing
Clinical narrative: Anaphylaxis after receiving MMRV+IPV+DTaP. Had received all before. Started with nausea, emesis, became diaphoretic and hypoxic to 87% SaO2. Developed wheezing and angioedema.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Affective disorder, Eczema, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: There was redness, swelling, and a knot at the injection site two weeks later. She broke out in eczema one week after the vaccine was administered. She had a hard time sleeping and controlling her moods.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Insomnia
Clinical narrative: There was redness, swelling, and a knot at the injection site two weeks later. She broke out in eczema one week after the vaccine was administered. She had a hard time sleeping and controlling her moods.
Age: 9.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Amnesia, Loss of consciousness, Tremor
Clinical narrative: Loss of consciousness, body tremors, memory loss.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Mother states pt. had a fever off and on from Sunday 04/23/17 to Tuesday 4/25/17, and woke up with a mild rash on stomach, arms, legs, and face that resembles chickenpox. RN encouraged mother to call and follow-up with pt.'s PCP today 04/26/17, mother stated that she would.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash papular, Swelling face
Clinical narrative: Patient Developed a fever up to 103, 3 days after vaccine. This lasted for 2 days. 5 days after vaccine, patient developed a rash. Rash worsened for 3 days, then improved for 2 days, then worsened again.  Patient was evaluated in the medical office 12 days after vaccinc and still had significant diffuse erythematous fine papular rash over the entire body and some puffiness of the face. This was treated with Prednisolone and Benadryl.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Blister, Diarrhoea, Rash
Clinical narrative: Patient experience diarrhea and broke out in a rash. Patient also had blisters on his skin.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Unable to reach parent. Messages left no response.
Age: 26.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus, Throat tightness
Clinical narrative: REDNESS AND ITCHING AT INJECTION SITE AND FEELING OF THROAT CLOSING UP. TOOK BENADRYL WITH SOME RELIEF AND THEN URGENT CARE AND PRESCRIBE STEROIDS.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Lethargy
Clinical narrative: Inconsolable crying for over 8 hours, lethargy.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Diet refusal, Lethargy, Ocular icterus, Yellow skin
Clinical narrative: Hepatitis B vaccine caused yellowing of the skin and eyes, lethargic. Would not eat. Begin formula feeding with breast milk for two days with syringe and lots of daylight on skin. Begin improving after four days.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Rash, Vaccination site swelling
Clinical narrative: Initially had redness and swelling to vaccine administration in left tricep.  That resolved without incident but patient developed a rash to the left arm 10 days after the administration of the vaccine.  Not certain of time of day.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site scar, Injection site swelling, Myalgia
Clinical narrative: Intradermal flu vaccine - immediate raised up to a small ring and was red, muscle aches x 2 weeks.  4/18/17 employee complains injection site "has grown and has turned red". "There is a hard lump that has raised even more as time has went on. One provider thought it has turned to scar tissue."
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever. Redness below the site of injection. Instructed to take TYLENOL/MOTRIN for pain or fever. Take BENADRYL for itching.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning two adult patients in their 50's of unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, both patients were vaccinated with a dose of ZOSTAVAX vial (dose, frequency and route were not reported) lot # M032638 with an unknown expiration date, for immunization; in combination with Sterile diluent injection (lot # reported as L006550 and the expiration date was not provided). On an unknown date, both patients experienced swelling around injection site and swelling was as big as lemon for both patients. They went to see the pharmacist about swelling and BENADRYL was recommended. On an unspecified date, the patients' swelling went down "within a week or so" after taking BENADRYL and they were reported as recovered from the adverse event. The causality between the adverse event and ZOSTAVAX and the sterile diluent was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: Information was received from a pharmacist via a company representative concerning an unspecified number of patients (demographics not provided). On unknown dates, the pharmacist reported that he administered subcutaneous injections of foamy ZOSTAVAX 19400 PFU (lot # unknown) to unspecified patients. Because of the foamy ZOSTAVAX, the patients may not have received a full dose of ZOSTAVAX although the pharmacist reported giving the patients single 0.65 ml injections. No adverse effect reported. No further information provided. Product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a 4 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with 4 improperly stored doses of PROQUAD lot # M017334, expiration date 05-OCT-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit (40F) for 15 hours. A digital data logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 13 year old patient of an unknown gender. The patient's concurrent conditions, medical history or concomitant medication were not reported. On 28-MAR-2017, the patient was vaccinated with PROQUAD with lot # M042500 and an expiration date of 17-APR-2018 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 12-APR-2017, the patient was vaccinated with one dose of improperly stored VARIVAX, (lot#, expiry date, route of administration and anatomical location were not reported). No adverse experience was reported. The data logger was involved. VARIVAX, went through the following excursion: Temperature/Time frame: -14 Celsius degrees to -10 Celsius degrees for 30 minutes; -9 Celsius degrees to 8 Celsius degrees for 5 hours. There was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Neurological symptom
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiry date were not reported). On an unknown date, the patient experienced unspecified neurological symptoms. The outcome of the event and the relatedness between the event and GARDASIL 9 were not reported.      Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 73-year-old female patient. The patient did not have any known drug reactions or allergies and her medical history included myasthenia gravis. On 11-APR-2017, the patient was vaccinated with a ZOSTAVAX for shingles prevention (dose, route of administration, lot# and expiration date were not reported). In approximately April 2017, the patient experienced swollen area at unspecified injection site that was initially size of a 50 cent. The swollen area expanded to several inches and was also warm, slightly firm and tender, on an unknown date in approximately April 2017. The patient experienced also fatigue, in approximately April 2017. The patient sought medical attention and phoned to the pharmacist, on an unknown date. No laboratory tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Insomnia
Clinical narrative: This spontaneous report was received from a nurse who was referring to 6 unspecified patients of unknown age and gender. The patients had no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On unknown dates, 6 patients were vaccinated with PNEUMOVAX 23 lot number M042324, expiration date 10-JUN-2018, intramuscularly (dose was not reported) for prophylaxis. On unknown dates, the patients experienced swelling at the injection site to the size of an apple and pain at the injection site to the point where they were unable to sleep for one week. It was not reported if the patients received any treatment for adverse events or sought medical attention. The outcome of the events was reported as unknown. The nurse requested lot check for PNEUMOVAX 23 lot number M042324. The relatedness between adverse events and suspect therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers 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 13-APR-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # M032149, expiration date: 18-APR-2019 (dose, site and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion in the range 47 to 77 degrees Fahrenheit for 40 minutes.  Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a medical assistant concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 14-APR-2017, the patient was inadvertently administered an expired dose of GARDASIL lot # K006960, expiration date 19-FEB-2017 (dosage and route of administration not provided).  No adverse effect reported. No additional information provided.       Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a consumer via Company Representative referring to a 67 year old female patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 12-APR-2017, the patient was vaccinated with PNEUMOVAX 23 for prevention pneumococcal infection (route of administration, lot number, expiration date, dose and anatomical location were not provided). Following this, on 13-APR-2017, the patient experienced "localized swelling" around the injection site (unspecified arm) "severe pain" and "fluid on the bottom of her arm". On 13-APR-2017 the patient sought medical attention and was given unspecified steroids as treatment for the mentioned events. At the time of reporting, the patient was recovering from "localized swelling" and "severe pain" but still experienced "fluid on the bottom of her arm". Additionally, the reporter did not provided causal relationship between the events and vaccination with PNEUMOVAX 23. There was not product quality complaint involved. Additional information is not expected since there are no contact details.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-MAR-2017, the patient was vaccinated with a first dose of VARIVAX, subcutaneously (site of administration, lot number and expiry date were not reported). On 24-MAR-2017, the patient received the second dose of VARIVAX, subcutaneously, lot # M028549, expiry date 07-JUN-2018 (site of administration was not reported) with sterile diluent (manufacturer unknown) (dose, lot # and expiry date were not reported). No side effects reported. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Viral upper respiratory tract infection
Clinical narrative: Information has been received from a physician referring to a 15 month old male patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 10-APR-2017, the patient was vaccinated with a dose of M-M-R II (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis and a dose of VARIVAX (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis. On 15-APR-2017, the physician reported that an additional dose of M-M-R II (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis and an additional dose of VARIVAX (route of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis were administered. On 15-APR-2017, the patient experienced a temperature of 101 degrees and cold signs and symptoms. Furthermore, it was reported that the patient did not received treatment for the reported events. At the time of the reporting, the patient had not recovered from temperature of 101 degrees and cold signs and symptoms. Additionally, the reporter did not provided causal relationship between the events and vaccination with M-M-R II and VARIVAX. There was not product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a registered nurse concerning multiple patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX with lot number M006729 and expiration date on 08-FEB-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent. The reporter stated that the diluent (lot number and expiration date were unknown) was stored properly. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 6 hours and 35 minutes. There was previous temperature excursion between -14 Centigrade degrees and -10 Centigrade degrees for 35 minutes and another excursion between -9 and 8 Centigrade degrees for 2 hours and 10 minutes. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009912:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 17-APR-2017, the patient was inadvertently vaccinated with a partial dose of PROQUAD subcutaneous injection (dose and frequency were not reported) lot # M035143 with expiration date of 30-JAN-2018, that was reconstituted with diluent MRK (lot # M029682 with expiration date of 12-JAN-2019), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus infection, Rotavirus test positive, Vaccination failure
Clinical narrative: This spontaneous report has been received from a physician referring to two to three patients of unknown age or gender. The patients had not medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On unknown dates, the patients were vaccinated with the first, the second and the third doses of ROTATEQ (strength, dose, route, lot # and expiration date were not reported) by oral route as rotavirus vaccination. Approximately in 2017 (reported as over last couple of months), the patients were diagnosed with rotavirus, after the patients had completed the 3 dose series of ROTATEQ. Stool samples were sent on an unspecified date to an unspecified laboratory, for confirmation of rotavirus and the results from the laboratory were positive for rotavirus. The patients were treated and subsequently, on unknown dates in 2017, they recovered from the event. No additional information was provided. The causal relationship between the event and the suspect therapy was not provided. Upon internal review the gastroenteritis rotavirus was considered as a medically significant event. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a physician assistant referring to an 83 year old female patient with no drug reactions or allergies. The patient's concurrent condition included hypertension, acid reflux and chronic obstructive pulmonary disease (COPD) (with oxygen). Concomitant therapies included aspirin(manufacturer unknown), atorvastatin, omeprazole, albuterol, tiotropium bromide (SPIRIVA), hydrochlorothiazide (HCTZ) and ipratropium bromide (ATROVENT).  On 18-APR-2017 the patient was vaccinated with a dose of PNEUMOVAX23 lot # M038359, expiration date 13-MAY-2018 (dose and frequency were not reported) intramuscularly in the left deltoid for prophylaxis. On 18-APR-2017  the patient contacted office that overnight she developed from injection site swelling, erythema, pain in her left arm, radiating pain to chest. The patient was being treated with sulfamethoxazole (+) trimethoprim (BACTRIM) "800/400" (unit unspecific) twice daily for 7 days. The outcome of the events was not recovered at the time of report. Causality between the events and PNEUMOVAX23 was not reported.The reporter stated another reaction she reported with same lot (same reporter link MARRS# 1704USA006512) and office did not plan to use further doses from this lot. Additional information has been requested; Sender's Comments:  US-009507513-1704USA006512: