chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Gait disturbance, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old female patient. The patient's concurrent conditions were not reported. The patient's drug reactions, allergies and concomitant medications were not reported. On 18-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, units and frequency not reported) (lot # N012127 and expiration date: 20-JAN-2019) on upper thigh, left lateral thigh muscle. It was reported that the patient had Flu shots (influenza virus vaccine inactivated (unspecified)) before, at the same time, on the opposite side. On 18-OCT-2017, patient had excruciating pain (pain), the patient could hardly walk (gait disturbance). It was reported that the patient took till that night to start feeling better, took a week just to sit down to use restroom. The outcome of the events excruciating pain was recovering and outcome of gait disturbance was unknown. The reporter did not provide the causal relationship for the events with suspect therapy PNEUMOVAX 23. This is one of the 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1710USA009526: US-009507513-1805USA007660:
Sex: M
Vaccine: MENB
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a non-contactable consumer (parent). A male patient of an unspecified age receive TRUMENBA, 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. It was reported that the patient has been 'sick' for 7 years most likely due to the vaccine. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: This is a spontaneous report from contactable nurse via a Pfizer Sales Representative. A 16 year-old male patient received TRUMENBA and MENVEO, both via an unspecified route of administration at single dose on the same unspecified day in May2018 for immunization. The patient medical history and concomitant medications were not reported. Approximately 3 hours post immunization the patient reported having severe arm pain, fatigue and feeling not right. He was told to go to Emergency Room and he did. All symptoms resolved 2 days post vaccination.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MENB, MNQ
Symptoms: Head injury, Loss of consciousness, Syncope, Tooth fracture, Vomiting
Clinical narrative: Pt in office for yearly check up. Pt. administered vaccines listed above and tolerated procedure well. Afterwards Patient was standing at registration desk with mother checking out, when she had a syncopal event witnessed by staff. Pt. hit head, chipped tooth. Pt. had positive LOC for approximately 30 seconds. Pt. woke up alert and oriented. EMS called at this time for transport and further evaluation. Pt. noted to have one emesis before arrival of EMS. Pt. denies chest pain or trouble breathing. No rash or hives noted.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Bedridden, Fatigue, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient with nausea, vomiting, fatigue and arm pain. "Bedridden" for 4 days.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Confusional state, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of runny nose in a 33-year-old female patient who received HAVRIX. On 4th May 2018, the patient received HAVRIX (intramuscular). On 7th May 2018, 3 days after receiving HAVRIX, the patient experienced influenza-like symptoms and tiredness. On 10th May 2018, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. On an unknown date, the patient experienced breast feeding. On an unknown date, the outcome of the runny nose was recovering/resolving and the outcome of the headache, memory impairment and sore throat were not recovered/not resolved and the outcome of the muscle soreness, decreased appetite, confusion, influenza-like symptoms, dizziness and tiredness were recovered/resolved and the outcome of the general body pain was not reported and the outcome of the breast feeding was unknown. The reporter considered the runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, influenza-like symptoms, general body pain, sore throat, dizziness and tiredness to be probably related to HAVRIX. See case US2018085809 for details regarding the baby case. Additional details were provided as follows: The patient's concomitant medications included birth control pills. The patient received the vaccine due to her job requiring the vaccination. The patient received HAVRIX in the left arm. The patient started to feel tired and have flu like symptoms.  The reporter stated the rest of the symptoms started on 10th May 2018. Six days after vaccination, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. The reporter stated all symptoms were gone except headache. The reporter stated she did call her healthcare professional and they instructed her to call GlaxoSmithKline. No healthcare professional information was provided.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Influenza like illness, Memory impairment, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of runny nose in a 33-year-old female patient who received HAVRIX. On 4th May 2018, the patient received HAVRIX (intramuscular). On 7th May 2018, 3 days after receiving HAVRIX, the patient experienced influenza-like symptoms and tiredness. On 10th May 2018, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. On an unknown date, the patient experienced breast feeding. On an unknown date, the outcome of the runny nose was recovering/resolving and the outcome of the headache, memory impairment and sore throat were not recovered/not resolved and the outcome of the muscle soreness, decreased appetite, confusion, influenza-like symptoms, dizziness and tiredness were recovered/resolved and the outcome of the general body pain was not reported and the outcome of the breast feeding was unknown. The reporter considered the runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, influenza-like symptoms, general body pain, sore throat, dizziness and tiredness to be probably related to HAVRIX. See case US2018085809 for details regarding the baby case. Additional details were provided as follows: The patient's concomitant medications included birth control pills. The patient received the vaccine due to her job requiring the vaccination. The patient received HAVRIX in the left arm. The patient started to feel tired and have flu like symptoms.  The reporter stated the rest of the symptoms started on 10th May 2018. Six days after vaccination, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. The reporter stated all symptoms were gone except headache. The reporter stated she did call her healthcare professional and they instructed her to call GlaxoSmithKline. No healthcare professional information was provided.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Rhinorrhoea
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of runny nose in a 33-year-old female patient who received HAVRIX. On 4th May 2018, the patient received HAVRIX (intramuscular). On 7th May 2018, 3 days after receiving HAVRIX, the patient experienced influenza-like symptoms and tiredness. On 10th May 2018, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. On an unknown date, the patient experienced breast feeding. On an unknown date, the outcome of the runny nose was recovering/resolving and the outcome of the headache, memory impairment and sore throat were not recovered/not resolved and the outcome of the muscle soreness, decreased appetite, confusion, influenza-like symptoms, dizziness and tiredness were recovered/resolved and the outcome of the general body pain was not reported and the outcome of the breast feeding was unknown. The reporter considered the runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, influenza-like symptoms, general body pain, sore throat, dizziness and tiredness to be probably related to HAVRIX. See case US2018085809 for details regarding the baby case. Additional details were provided as follows: The patient's concomitant medications included birth control pills. The patient received the vaccine due to her job requiring the vaccination. The patient received HAVRIX in the left arm. The patient started to feel tired and have flu like symptoms.  The reporter stated the rest of the symptoms started on 10th May 2018. Six days after vaccination, the patient experienced runny nose, headache, muscle soreness, decreased appetite, confusion, memory impairment, general body pain, sore throat and dizziness. The reporter stated all symptoms were gone except headache. The reporter stated she did call her healthcare professional and they instructed her to call GlaxoSmithKline. No healthcare professional information was provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The patient had redness and itching at the injection site starting the day after injection and lasting for 1 week. It resolved on its own with no treatment.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large area of redness, swelling and tenderness of Left shoulder.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Hot flush, Nausea
Clinical narrative: Patient called the morning after receiving a Hepatitis B vaccine. First injection in a series of 3 injections. Patient is a new employee. Patient stated she felt well upon leaving the work after a 15 minute waiting period after injection. States that when she got home she ate a meal and a short time later began feeling mildly nauseated. The following morning patient states she felt severely nauseated and was having hot flashes and an upset stomach. Patient denied having any swelling, pain or itching at the injection site and denied having any difficulty breathing or any oropharyngeal swelling.
Age: 12.0
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Vasovagal syncope with loss of bladder control. PCP notified. Father instructed to follow up with PCP. Pt. recovered in office, A plus o x3, sent home with parent.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, heat, and tenderness to palpation of (R) upper arm starting one day after receiving immunization at time o f well child exam.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site discolouration, Injection site reaction, Skin lesion
Clinical narrative: Pt seen in office 5-25-2018- Rt thigh with Central blue hue and circle around it. PROQUAD vaccine was given rt thight 5 days ago. Pict taken lesion 4x4 cm with ring halo.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Serum sickness-like reaction, Swelling face
Clinical narrative: Serum sickness like rash. Mild facial swelling, fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen and warm to the touch.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Nausea, headache, fatigue, pain at injection site muscle pain for 24 hours after.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Swelling
Clinical narrative: Redness and swelling developed after injection, redness site spread across entire thigh.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Pain in extremity, Tremor
Clinical narrative: Mother states patient went home and took a nap and when she woke up her arm was hurting her really bad and she was shaky and was having shortness of breath. Mother rook her to urgent care, her O2 was 88% on RA and was put on oxygen via nasal canula her O2 went up from 88% to 90%  and was given a DECADRON 8mg/ml she received 1 mg IM PA-C on right gluteus. Patient declined EPI and BENADRYL injections. Urgent care wanted to have her transported to Hospital VIA ambulance but patient refused due to her starting to feel better.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Dry mouth, Fatigue, Feeling cold, Feeling hot
Clinical narrative: Headache, Body aches,Dry mouth,Back pain,tired,Cold/hot feeling,sweating.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Hyperhidrosis, Pain
Clinical narrative: Headache, Body aches,Dry mouth,Back pain,tired,Cold/hot feeling,sweating.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Pyrexia
Clinical narrative: Fever and chills for 48 hours. Injection very sore 3 days. Redness lasted a week.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Malaise, Unresponsive to stimuli
Clinical narrative: Patient wasn't feeling well directly after injection, then passed out for several minutes, and was non-verbal for at least 15 minutes till started feeling better.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Scattered body rash (arms, stomach, back, and head) with major itching.
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient's historical drugs, medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK). On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On an unknown date, the patient had angioedema reaction. It was unknown if the patient received any treatment or if diagnostic laboratories were performed. At the time of reporting, the outcome of angioedema was unknown. Additionally, the causality assessment between angioedema and ZOSTAVAX was not provided. Upon internal review, angioedema was determined to be a medically significant event.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This ae was reported to field employee. The primary reporter is Administrator. Administrator reports on an unspecified date an unspecified 27 year old patient was administered a dose of GARDASIL 9 (unknown lot/exp). No adverse effects. No additional information. This spontaneous report as received from an administrator refers to a 27-year-old patient. The patient's medical history was not reported. On an unknown date, a dose of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) was administered to the 27-year-old patient for prophylaxis No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In September 2011, the patient was inoculated with ZOSTAVAX at medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 09-OCT-2015, the patient was treated at the same medical center for a blistering vesicular outbreak that was diagnosed as herpes zoster conjunctivitis. She was prescribed gabapentin and acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Pyrexia, Rash, Rash pruritic
Clinical narrative: 2 days following vaccination patient began having fever and chills. 3 days later breaking out of RASH on face and few spots on arms and legs. Patient described as painful and itchy. 3 to 4 days later fever dissipated, and appetite returned. As of today 5/25/2018 patient is feeling better and taking BENADRYL which patient says has helped.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Basedow's disease, Palpitations, Radioactive iodine therapy, Weight decreased
Clinical narrative: Reported that he began to experience weight loss and palpitations shortly after the administration of his first anthrax vaccine. Symptoms continued, he sought medical evaluation where he was diagnosis with Graves' disease and underwent ablation. He is currently on thyroid replacement. He denies family hx of thyroid disease. Symptoms: PALPITATIONS(R002), ABNORMAL WEIGHT LOSS(R634).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Cough, Headache, Hyperhidrosis
Clinical narrative: Started around 10:30pm and continued until about 5am: All over muscle and joint ache, chills, shivering, headache, thirst, sweating, unable to take a deep breath without coughing. Time of injection for 24 hours: lingering pain at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Thirst
Clinical narrative: Started around 10:30pm and continued until about 5am: All over muscle and joint ache, chills, shivering, headache, thirst, sweating, unable to take a deep breath without coughing. Time of injection for 24 hours: lingering pain at injection site.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pt called with swelling in arm nearer to injection site. Said it was a hard lump and she had some pain. Today (5/25/18) pt calls and says she can move her arm and the hard swelling spot is gone. However, she says her arm is swelling (a soft swelling). She no longer has pain and can move her arm. She has been advised to take an anti-inflammatory. Also advised to contact her physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature decreased, Chills, Headache, Myalgia
Clinical narrative: Shivers, low temperature, headache, joint and muscle aches; 6-7 hours sleep, 2 acetaminophen.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Swelling of right thigh from hip to knee.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Delirium, Influenza like illness, Injection site irritation, Injection site pain
Clinical narrative: Flu like symptoms (shaking, chills, delirium) injection site irritation (pain at injection site).
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Flu like symptoms (shaking, chills, delirium) injection site irritation (pain at injection site).
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: Flu like symptoms (shaking, chills, delirium) injection site irritation (pain at injection site).
Age: 35.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Red, tender with mild warmth and swelling.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Headache, Impaired work ability, Injection site pain
Clinical narrative: Headache, soreness at the injection sight, muscle aches, extreme fatigue. After 2 days developed a stiff neck, sore throat, nasal congestion and a terrible cough. At the time of filling out this report have not been able to work.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Headache, soreness at the injection sight, muscle aches, extreme fatigue. After 2 days developed a stiff neck, sore throat, nasal congestion and a terrible cough. At the time of filling out this report have not been able to work.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Nuclear magnetic resonance imaging
Clinical narrative: Bells palsy left side of face.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bells palsy left side of face.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given the pediatric dose of Hepatitis A vaccine, she had no serious reaction or any medical issues following injection.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Left arm in the area of the deltoid muscle had a large reddened area about 4 inches in diameter with uneven edges and was warm to the touch. Patient has been taking his regular dose of morphine and an anti-inflammatory whose name he could not remember. He said his arm was painful. He said he would contact his physician.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Toothache
Clinical narrative: About 8 hours after shot had headache and bad chills. Was in bed for about 12 hours. Woke with back pain and even teeth seemed to hurt. I had no reaction ex a sore arm from the 1st shot.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV
Symptoms: Body temperature increased, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Widespread macular examthem. Temp of 100.7. Dizzy, tired, headache, and nausea. No treatment required.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV
Symptoms: Rash generalised, Rash macular
Clinical narrative: Widespread macular examthem. Temp of 100.7. Dizzy, tired, headache, and nausea. No treatment required.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at the site of injection.
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified 6 month old patients of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, during measles outbreak, the patients were vaccinated with M-M-R II injection (dose, frequency, site of administration, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Multiple allergies
Clinical narrative: This spontaneous report was received from an unknown age female consumer via company representative reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date in 2017 (also reported as "last year"), the patient was vaccinated with hepatitis b vaccine (manufacturer unknown), (dose, frequency, dose number, route, anatomical location, lot number and expiration date were not reported), for prophylaxis, as part of her job-related immunization requirements. No other suspect or concomitant therapies were reported. On an unknown date in 2017 (also reported as "ever since the shot"), the patient had been suffering from multiple unexplained allergic reactions (multiple allergies), that she never had before the "shot". At the time of reporting, the outcome of multiple allergies and the causal relationship between the multiple allergies and the therapy with hepatitis b vaccine (manufacturer unknown) were unknown.
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 10-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patient was vaccinated with two doses of M-M-R II injection (dose, route of administration, lot number and expiration date were not reported) as a standard of care. On an unknown date, the patient experienced mumps. The company representative added, there was a mumps outbreak at the patient's area. The outcome of the event was unknown. The relatedness between the event M-M-R II was not reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 12 year old male patient. The patient's medical history included hives due to penicillin allergy. Concomitant therapies included multivitamins. On an unknown date in 2017 (reported as "one year ago"), the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscular (lot # and expiration date unknown) to prevent human papillomavirus (HPV). On 05-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9 injection, intramuscular for prophylaxis. On 07-MAY-2018, the patient developed hives on unspecified areas of the body. As a result, on that day, the patient started 2 days of therapy with diphenhydramine hydrochloride (BENADRYL). On 09-MAY-2018, the patient went to see a physician and was started on 5 days of therapy with prednisone (manufacturer unknown) 30 mg twice daily. On 19-MAY-2018, the patient was started on therapy with cetirizine hydrochloride (ZYRTEC). The patient had not recovered at the time of reporting. No laboratories were performed for the event. The outcome of inappropriate schedule of drug administration was unknown. The reporter did not provide a causality assessment between the event and the suspect vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-APR-2011, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-FEB-2015, the patient was treated at the same medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-NOV-2011, the patient was inoculated with ZOSTAVAX at a lab as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-JUL-2014, the patient was treated at the same lab for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with ZOSTAVAX at a doctor's office/hospital as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2012, the patient was treated at the same doctor's office/hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Two days after PNEUMOVAX injection, patient developed redness and swelling on the left arm above the elbow, which appears to be a gravity dependent continuation of the upper elbow swelling. That started the day of the shot.
Age: 62.0
Sex: M
Vaccine: RAB
Symptoms: Amnesia, Loss of consciousness, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of loss of consciousness in a 62-year-old male patient who received RABAVERT (batch number 643011E, expiry date unknown). This case was associated with a product complaint. On an unknown date, the patient received RABAVERT. On 17th May 2018, less than a year after receiving RABAVERT, the patient experienced loss of consciousness (serious criteria GSK medically significant) and memory loss. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the loss of consciousness, memory loss and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the loss of consciousness and memory loss to be related to RABAVERT. Additional details were provided as follows: The nurse reported that the patient presented to office on the reporting date with memory loss and losing consciousness that started a day before. The nurse reported the patient stated that someone from GlaxoSmithKline called him and stated lot number was defective. The nurse reported they would assess and treat as appropriate. This case was linked with US2017GSK149004 and US2018026733, cases reported for same patient with pre-exposure schedule and booster dose of RABAVERT respectively.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reddened area in upper right arm. Warm to touch. Site is beneath injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Mobility decreased
Clinical narrative: Pain, severe swelling, muscle pain (could not move arm), headache, chills and shivering, upset stomach and extreme tiredness. I know these are common symptoms, but since I had almost all for 54 hours, I thought I should report them.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Swelling
Clinical narrative: Pain, severe swelling, muscle pain (could not move arm), headache, chills and shivering, upset stomach and extreme tiredness. I know these are common symptoms, but since I had almost all for 54 hours, I thought I should report them.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Emotional distress, Urticaria
Clinical narrative: After immunizations were administered patient was very upset and started to break out in hives.  We do not know if the hives were a result of the patient being upset or a reaction to the vaccine. BENADRYL 12.5 mg/5 mL Liquid Take 5 mL by mouth one time was given once the hives started.  Patient was monitored for 45 minutes after the hives started and was released because of improvement.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Tinnitus, Vomiting
Clinical narrative: Redness in face, throwing up, tinnitus, fever... pt reports had to start taking antivirals.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RV5, UNK
Symptoms: Eye movement disorder, Irritability, Pyrexia, Screaming
Clinical narrative: Uncontrolled screaming for hours (5+) for days on end. Resolved after a few weeks, recurred at every vaccination date subsequently. Eye turned in, fever, irritability.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient presented today with rash on neck. She said it was very similar to her shingles outbreak last April. It is red itchy patches. Most likely triggered dorment virus to become active. Patient is following up with PCP for treatment options.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Screaming
Clinical narrative: Uncontrolled screaming for hours (5+), fever.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness, Tinnitus
Clinical narrative: Patient complains of tinnitus in left ear. Exam normal with mild tenderness in ear. Patient referred to ENT.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site nodule, Injection site reaction, Injection site warmth
Clinical narrative: Presented with red lesion or nodular at the right anterior thigh after her vaccines at 12 months. Her vaccines were given about one week ago. It is in the location of the varicella vaccine. The area was red the following day and it slowly getting bigger. The redness is bigger and it seems warm. No streaks. No discharge. She had fever start last night to about 100 F. Treated with KEFLEX 125 mg/5 mL suspension 5/25/2018- 6/4/2018 Take 4 mL (100 mg) by mouth 3 times daily for 10 days. She is acting more tired and more fussy. Mother has given her acetaminophen.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Pyrexia, Skin lesion
Clinical narrative: Presented with red lesion or nodular at the right anterior thigh after her vaccines at 12 months. Her vaccines were given about one week ago. It is in the location of the varicella vaccine. The area was red the following day and it slowly getting bigger. The redness is bigger and it seems warm. No streaks. No discharge. She had fever start last night to about 100 F. Treated with KEFLEX 125 mg/5 mL suspension 5/25/2018- 6/4/2018 Take 4 mL (100 mg) by mouth 3 times daily for 10 days. She is acting more tired and more fussy. Mother has given her acetaminophen.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Pyrexia, Rash erythematous
Clinical narrative: Within a few hours after immunization administration: Chills, "sun burn" feeling over skin, polyarthralgias, fever 104, abdominal pain. Called triage line and was advised to report to local ER.  Patient did not go to ER. States he took TYLENOL, fever came down in an hour, and felt better by morning. Denies injection site problems.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Hypersomnia, Irritability, Lethargy, Rash
Clinical narrative: Rash, Extreme Irritability, Sleeping a lot since vaccine given, Lethargy, Very fussy when you hold him and touch him.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Skin exfoliation
Clinical narrative: Mother stated that child's hands and feet began peeling on 5/14/18. The child received vaccines on 5/4/18. She stated the child is healthy and the vaccinations had to be the cause of the peeling extremities. Mother stated that child was taken to a local nurse practitioner office and given steroid cream. The steroid cream has helped with the peeling. Mother requested VAERS form to be completed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: LOCAL REDNESS AND SWELLING OF LEFT ARM,  TREATMENT PLAN INCLUDES ICE, IBUPROFEN EVERY 6 HRS AS NEEDED, BENADRYL FOR ITCHING
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, MNQ, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: While preparing vaccines for administration at 9:36am on 5/24/18, the RN inadvertently pulled MENACTRA vials instead of the Sterile Diluent vials from the vaccine fridge. The MENACTRA vaccines were documented in place of the diluent. The MMR and Varicella vaccines were reconstituted with 0.5ml of MENACTRA each. Both vaccines were administered to the patient subcutaneously as documented. Error was discovered at the end of day on 5/24/18 - MD in office notified; ordering physician notified patient's parents the morning of 5/25/18. No adverse signs or symptoms reported at that time.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Vaccine conjugate expired 03/2018.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash macular, Skin warm
Clinical narrative: Patient developed red splotches all over left and right arm. There was one splotch on the face and leg. The left arm was warm to the touch. The rash did not hurt or itch. It began to subside about 24 hours later. Patient began taking BENADRYL on the evening of the 23rd.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Skin warm
Clinical narrative: Patient developed red splotches all over left and right arm. There was one splotch on the face and leg. The left arm was warm to the touch. The rash did not hurt or itch. It began to subside about 24 hours later. Patient began taking BENADRYL on the evening of the 23rd.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin exfoliation
Clinical narrative: Patient developed swelling and redness in arm that got the size of a tennis ball, after a several days the swelling subsided and about 9 days later her skin started peeling.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Gave expired vaccine expiration was 05/13/2018.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergic respiratory symptom, Cardiac failure congestive, Cough, Diarrhoea, Dyspnoea
Clinical narrative: On April 23, flu-like symptoms began with nausea and diarrhea. As those subsided, allergy-like symptoms began with a cough and wheezing (no history of asthma or previous wheezing). Primary care doctor prescribed VENTOLIN HFA for relief. Symptoms continued. Saw the clinic Nurse practitioner on May 16. She felt it was still allergy based. May 20, breathing was so difficult, he was taken to the Emergency Room and was admitted, diagnosed with viral cardiomyopathy.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Lung infiltration, Nausea, Oxygen saturation decreased, Pericardial effusion
Clinical narrative: On April 23, flu-like symptoms began with nausea and diarrhea. As those subsided, allergy-like symptoms began with a cough and wheezing (no history of asthma or previous wheezing). Primary care doctor prescribed VENTOLIN HFA for relief. Symptoms continued. Saw the clinic Nurse practitioner on May 16. She felt it was still allergy based. May 20, breathing was so difficult, he was taken to the Emergency Room and was admitted, diagnosed with viral cardiomyopathy.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Viral cardiomyopathy, Weight decreased, Wheezing
Clinical narrative: On April 23, flu-like symptoms began with nausea and diarrhea. As those subsided, allergy-like symptoms began with a cough and wheezing (no history of asthma or previous wheezing). Primary care doctor prescribed VENTOLIN HFA for relief. Symptoms continued. Saw the clinic Nurse practitioner on May 16. She felt it was still allergy based. May 20, breathing was so difficult, he was taken to the Emergency Room and was admitted, diagnosed with viral cardiomyopathy.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Headache
Clinical narrative: Dull headache lasting from 11 p.m. on first day to 3:50 p.m. the next day and still going.
Age: 67.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Nerve compression, Pain, Peripheral swelling
Clinical narrative: Per patient report, patient stated she received vaccinations in left shoulder/arm and then afterwards, arm swelled and patient still in pain. PCP told patient she has a pinched nerve. Unclear whether any further treatment will be given to patient but pharmacy will follow up with PCP.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Muscle twitching, Pruritus
Clinical narrative: Muscle twitching, pain at injection site, itching (patient had both arms injected, left is causing more pain, both arms itching). Itching did not begin until 5 days later.
Age: 47.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Flushing, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: About an hour after vaccination, patient experienced tingling sensation at tongue, swelling at throat, and flushing at neck and face. Immediate BENADRYL administration resulted relief of the symptoms.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Extreme fatigue 5 days, myalgia 5 days, chills 3 days, fever 3 days, pain at injection site 5 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse effect yet, however there may have been a faulty syringe. When injecting the vaccine I (the pharmacist) didn't feel resistance from the syringe and the needle seemed to retract sooner than usual. Kathy's initial reaction was "that was it?" as she didn't feel the injection, when speaking with her again she said she felt something...On inspection of the syringe there was more fluid than usual, possibly 0.2ml in the back of the syringe.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Intraocular pressure increased
Clinical narrative: Pt reported an increase in intraocular pressure 2 days after vaccination.  She came back to recheck in 2 weeks and it was within normal limits.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Fatigue, Inflammation, Injection site swelling
Clinical narrative: Administered vaccine just below left deltoid in the bicep brachii region (information provided by her MD after examination) instead of deltoid muscle. Redness and inflammation occurred the same day with swelling around the injection site. The patient called the pharmacy and was instructed to apply cold compress to the zone after noticing the redness and swelling in the days after the injection. Patient also took advil for the swelling. Patient reported that she was unable to sleep on her left side from pain resulting from the adverse event. The patient saw a MD May 18th because of how tired she was feeling and blood was drawn on May 22 for routine blood work.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Product administered at inappropriate site
Clinical narrative: Administered vaccine just below left deltoid in the bicep brachii region (information provided by her MD after examination) instead of deltoid muscle. Redness and inflammation occurred the same day with swelling around the injection site. The patient called the pharmacy and was instructed to apply cold compress to the zone after noticing the redness and swelling in the days after the injection. Patient also took advil for the swelling. Patient reported that she was unable to sleep on her left side from pain resulting from the adverse event. The patient saw a MD May 18th because of how tired she was feeling and blood was drawn on May 22 for routine blood work.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Excruciating shoulder pain resulting from what was determined by Dr. to be an improperly administered PNEUMOCOCCAL VACCINE,23-VALENT into the bursa of my right shoulder.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Patient has muscle aches throughout her body not just the injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye disorder, Fatigue, Glaucoma
Clinical narrative: Affected the eye; white spots like glaucoma appeared 2 days after the vaccination, and has persisted. Pt also reports fatigue.
Age: 66.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Left Arm: Warm, tender, red, swollen, increased tenderness Plan: Ice to arm, ZYRTEC PO Q day, BENADRYL Q HS X 3 days, Clindamycin 250mg BID X 7days. Pt left clinic in stable condition
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Formication, Pain, Pain in extremity
Clinical narrative: Patient reports arm pain which began when he had the vaccination. He states that the pain sometimes travels up towards his neck or down toward his hand and hurts when he raises his arm above a certain level. He also sometimes experiences what he described like crawling feelings on his arm.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Rash
Clinical narrative: RASH TO RIGHT ABDOMEN AND LEG.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Fatigue sleeping nighttime + 6 hrs daytime.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Low grade fever-was gone within 36 hours of vaccine. Pain in back muscles has not gone away as of 5-23-18.