chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by pharmacist (via a Pfizer sales representative) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 730415), concerns a patient of an unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with, influenza vaccine (anatomical location: arm, dose, route of administration, manufacturer, tradename, batch number and expiry date: not reported). On an unspecified date, the patient was administered with non-company suspect product PREVNAR 13 (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported). It was reported that patient received the both vaccines in the same arm with an inch apart. On an unspecified date in 2017 (reported as between Sep-2017 and Nov-2017), after administration of vaccines, the patient's arm was hurt, was swollen and had a lump on it. On an unspecified date in 2017, the patient had completely recovered from the events (limb mass, swollen arm and pain). The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by consumer (reporting on herself) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 730457), concerning a female patient of an unspecified age. The patient's medical history and concomitant medication were not reported. On an unspecified date in 2013, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, following vaccination, the patient developed hives on her chest, arms, thighs and calves. Relevant lab test and corrective treatment were not reported. On an unspecified date, the patient had recovered from the event. The reporter considered this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 730522), concerns a female patient of unspecified age. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, batch number, expiry date, trade name was not reported). The outcome of the event was not reported. The reporter assessed the case as non-serious.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Blood test normal, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: This is serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 730536), concerning a 75-year-old, elderly, female patient. It was reported that, on an unknown date patient's body height decreased. Current conditions included blood clots (diagnosed in 1965) and atrial fibrillation (since an unknown date). The patient's concomitant medication included COUMADIN. On 05-Oct-2017, the patient administered with influenza vaccine (route of administration, dose: unk (as reported), anatomical location: right arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient also administered with PREVNAR 13 (route of administration: un, dose: unk (as reported), anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day (05-Oct-2017), after vaccine administration, the patient had no appetite at all and she did not eat anything solid for one week (she wanted only Coca-Cola). The patient also had diarrhea, and complete fatigue. When she woke up, the next day and her head was splitting open. On unknown date, the patient lost her weight and she was feeling abnormal. She did not have any desire for sweets and things almost made her feel like she would throw up, just like nausea. She was too sick to go to the family doctor and could not walk from one room to the next because she had no breathe. She was too weak to get up. It had been almost two months, she had no energy. On 06-Oct-2017, the patient had sweat a lot when she woke up that night (Friday) (reported as she was wet). Her head was wet due to sweat on her forehead. On an unknown date, she went to her cardiologist. On 27-Nov-2017, different tests were performed as echocardiogram, thyroid function test, all blood tests and lung scan were found normal. At the time of this report, the patient had not recovered from the events.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Echocardiogram normal, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: This is serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 730536), concerning a 75-year-old, elderly, female patient. It was reported that, on an unknown date patient's body height decreased. Current conditions included blood clots (diagnosed in 1965) and atrial fibrillation (since an unknown date). The patient's concomitant medication included COUMADIN. On 05-Oct-2017, the patient administered with influenza vaccine (route of administration, dose: unk (as reported), anatomical location: right arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient also administered with PREVNAR 13 (route of administration: un, dose: unk (as reported), anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day (05-Oct-2017), after vaccine administration, the patient had no appetite at all and she did not eat anything solid for one week (she wanted only Coca-Cola). The patient also had diarrhea, and complete fatigue. When she woke up, the next day and her head was splitting open. On unknown date, the patient lost her weight and she was feeling abnormal. She did not have any desire for sweets and things almost made her feel like she would throw up, just like nausea. She was too sick to go to the family doctor and could not walk from one room to the next because she had no breathe. She was too weak to get up. It had been almost two months, she had no energy. On 06-Oct-2017, the patient had sweat a lot when she woke up that night (Friday) (reported as she was wet). Her head was wet due to sweat on her forehead. On an unknown date, she went to her cardiologist. On 27-Nov-2017, different tests were performed as echocardiogram, thyroid function test, all blood tests and lung scan were found normal. At the time of this report, the patient had not recovered from the events.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Nausea, Night sweats, Thyroid function test normal, Ventilation/perfusion scan, Weight decreased
Clinical narrative: This is serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 730536), concerning a 75-year-old, elderly, female patient. It was reported that, on an unknown date patient's body height decreased. Current conditions included blood clots (diagnosed in 1965) and atrial fibrillation (since an unknown date). The patient's concomitant medication included COUMADIN. On 05-Oct-2017, the patient administered with influenza vaccine (route of administration, dose: unk (as reported), anatomical location: right arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient also administered with PREVNAR 13 (route of administration: un, dose: unk (as reported), anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day (05-Oct-2017), after vaccine administration, the patient had no appetite at all and she did not eat anything solid for one week (she wanted only Coca-Cola). The patient also had diarrhea, and complete fatigue. When she woke up, the next day and her head was splitting open. On unknown date, the patient lost her weight and she was feeling abnormal. She did not have any desire for sweets and things almost made her feel like she would throw up, just like nausea. She was too sick to go to the family doctor and could not walk from one room to the next because she had no breathe. She was too weak to get up. It had been almost two months, she had no energy. On 06-Oct-2017, the patient had sweat a lot when she woke up that night (Friday) (reported as she was wet). Her head was wet due to sweat on her forehead. On an unknown date, she went to her cardiologist. On 27-Nov-2017, different tests were performed as echocardiogram, thyroid function test, all blood tests and lung scan were found normal. At the time of this report, the patient had not recovered from the events.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS: 730915), concerning 78-year-old, male patient. The patient's medical history was not reported. On 04-Oct-2017, the patient was administered with Influenza vaccine (dose: unk, route of administration: unk, anatomical location: unk, trade name, batch number and expiry date: not reported) for an unknown indication. On the same day, after administration of vaccine, the patient experienced headache. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Acne, Amnesia, Asthenia, Back pain, Burning sensation
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Cognitive disorder, Confusional state, Depression, Dizziness, Fatigue
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Hypersensitivity, Hypoaesthesia, Inappropriate affect, Migraine, Muscular weakness
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Myalgia, Paraesthesia, Rash, Skin discolouration, Syncope
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Tinnitus
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Antinuclear antibody negative, Borrelia test negative, C-reactive protein normal, Confusional state, Disturbance in attention
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Dizziness, Full blood count normal, Headache, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Raynaud's phenomenon, Red blood cell sedimentation rate normal
Clinical narrative: Starting about 1 month after the vaccination, she developed worsening frequency and intensity of headaches, and dizziness. Symptoms progressed to Raynaud-type SXs of hands, paresthesias of hands and feet, episodes of poor concentration and confusion. She continues to have these SXs. She has been evaluated by her neurologist on several occasions, a cardiologist and rheumatologist because of progressive and disparate SXs.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Blood test normal, Gastrointestinal pain, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt stated that 8 hrs after receiving the vaccine, she got stomach cramps, low blood pressure, increase heart rate, dizziness, lightheaded, nausea. When she saw the doctor the next morning, her symptoms went away. Pt stated that her doctor told her to just take fluids.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Pt stated that 8 hrs after receiving the vaccine, she got stomach cramps, low blood pressure, increase heart rate, dizziness, lightheaded, nausea. When she saw the doctor the next morning, her symptoms went away. Pt stated that her doctor told her to just take fluids.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Dizziness, Heart rate increased, Hypotension, Nausea
Clinical narrative: Pt stated that 8 hrs after receiving the vaccine, she got stomach cramps, low blood pressure, increase heart rate, dizziness, lightheaded, nausea. When she saw the doctor the next morning, her symptoms went away. Pt stated that her doctor told her to just take fluids.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness, Fall, Heart rate increased, Hyperhidrosis
Clinical narrative: Pt stated that 8 hrs after receiving the vaccine, she got stomach cramps, low blood pressure, increase heart rate, dizziness, lightheaded, nausea. When she saw the doctor the next morning, her symptoms went away. Pt stated that her doctor told her to just take fluids.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypotension, Motion sickness, Muscular weakness, Nausea
Clinical narrative: Pt stated that 8 hrs after receiving the vaccine, she got stomach cramps, low blood pressure, increase heart rate, dizziness, lightheaded, nausea. When she saw the doctor the next morning, her symptoms went away. Pt stated that her doctor told her to just take fluids.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Dyskinesia, Ear infection
Clinical narrative: Baby looks like she has involuntary movements with her head and she?s is nodding her head at random wall moments in a jerking motion burn hrs in betweenness.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Projectile vomiting at bed time 9 pm and fever 99.7 underarm at 9:45 pm will take to Dr in morning if not better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever beginning the afternoon of the injection, spiked to over 101 degrees that evening. The second day fever varied up and down from a "normal" temperature to just under 100 degrees. No fever on day 3. Extreme arm soreness that lessened over time.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash on chest, back and stomach, may have ran fever last night but parent was not sure. Infant does not act like rash bothers her notice rash the next morning after vaccines.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dyskinesia, Injection site pain, Insomnia, Pain
Clinical narrative: 24 hour follow-up: Patient reported he had a high fever and his heart was pounding to the point his body was jerking. He was unable to sleep that night. He had called his doctor who told him to go to the ER but the patient decided he was just going to try to sleep it off and if he did not feel better he would go to the ER. 72 hour follow-up: Patient reported that they are still weak and his whole body hurt not just the injection site. He stayed home all weekend and did not go to the ER and slept the whole weekend. He said he felt like his heart pounding out of his chest and was scared during the weekend. Patient had a phone call into his doctor's office. Pharmacy talked to doctor's office and they said for patient not to get the second dose of vaccine and if he is still feeling weak in a couple of days to call back and make appointment.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: 24 hour follow-up: Patient reported he had a high fever and his heart was pounding to the point his body was jerking. He was unable to sleep that night. He had called his doctor who told him to go to the ER but the patient decided he was just going to try to sleep it off and if he did not feel better he would go to the ER. 72 hour follow-up: Patient reported that they are still weak and his whole body hurt not just the injection site. He stayed home all weekend and did not go to the ER and slept the whole weekend. He said he felt like his heart pounding out of his chest and was scared during the weekend. Patient had a phone call into his doctor's office. Pharmacy talked to doctor's office and they said for patient not to get the second dose of vaccine and if he is still feeling weak in a couple of days to call back and make appointment.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients unknown ages and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with multiple doses of improperly stored LIQUID PEDVAXHIB lot # L038502 for prophylaxis, (route, dose and anatomical location not provided). The temperature and time frame were reported as follow: 47 degrees Fahrenheit to 77 degrees Fahrenheit (46.84 degrees Fahrenheit) for 15 minutes. There was no previous temperature excursion and the call was made because of a digital "data logger", There were not adverse events reported in any patients.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 80 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 20-MAR-2018, the patient was vaccinated with PREVNAR 13 for an unknown indication (dose, frequency, route of administration, lot number and expiration date were not reported). On 22-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  During 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended. During spring of 2016 the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On an unspecified date, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 15-APR-2016 the patient was treated at a health facility for the onset of a painful rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 20-JUN-2012, the patient was inoculated (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 25-APR-2016, the male patient was treated (by unspecified health care professional) at a clinic and surgery center, and was diagnosed with Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated at a medical group and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated by a Physician Assistant and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site inflammation, Injection site irritation, Injection site reaction, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated by a Physician Assistant and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated by a Physician Assistant and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-MAR-2010, the patient was inoculated at a clinic (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the female patient was treated (by unspecified health care professional) at a clinic for a persistent and severe rash, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated by a physician and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-OCT-2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about May 2016, the patient was treated by a physician and was diagnosed with herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-FEB-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 26-AUG-2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This initial 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 concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by her primary care physician and was diagnosed with herpes zoster, or shingles. The patient was prescribed FAMVIR and PERCOCET for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-OCT-2015, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route, administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 26-APR-2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a 38 year old female patient who was also a physician assistant. The patient did not have drug Reactions/Allergies and concomitant medications. Medical history and concurrent conditions were not reported. On 21-MAR-2018, the patient was vaccinated with VARIVAX (lot and expiry date not reported) as a job requirement because her varicella titers were low and she had no record of previous varicella vaccination. The day after vaccination (22-MAR-2018), the patient took a home pregnancy test that was positive. The patient said she was 4 weeks pregnant and her last menstrual period occurred on 21-FEB-2018. The date of conception was 07-MAR-2018 and the estimated due date for delivery was on 28-NOV-2018. The patient said that she had not seen a physician and said that she currently did not have a physician. No adverse clinical effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reactions/allergies were unknown. On 20-MAR-2018, the patient was vaccinated with an expired but properly stored dose of ZOSTAVAX 19400 PFU (lot # N012092, 13-MAR-2018) (route and dose unknown) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported.
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Chills, Headache, Injection site pruritus, Nausea
Clinical narrative: Initial unsolicited report received from physician on 19 Mar 2018. This case involves 74 years old female patient who was vaccinated with dose of INFLUENZA HIGH DOSE VACCINE (batch number, expiry date, route and site of administration were not reported) in right vastus on 08 Jan 2018. The patient's medical history and concomitant medication were not reported. On 12 Jan 2018 four days post vaccination patient reported that she had severe headache, burning, itching at the site, nausea no vomiting, teeth chattering and chills. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Mild fever. Aching in arm. Flu-like symptoms.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tiredness, very sore arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: SEVERE PAINFUL RASH. LASTED WEEK.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Depressed level of consciousness, Dysarthria, Facial paralysis, Injection site erythema
Clinical narrative: Within 6 hours of receiving the vaccine, patient experienced pain, redness, warmth at injection site. Left arm was painful and tingled and then spread to her left neck, face and head. Back pain on left side followed. Face felt 'droopy' and speech was slurred. Eyes red. She was nauseous and semi-conscious. She was seen in the emergency room.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site warmth, Nausea, Ocular hyperaemia, Pain in extremity
Clinical narrative: Within 6 hours of receiving the vaccine, patient experienced pain, redness, warmth at injection site. Left arm was painful and tingled and then spread to her left neck, face and head. Back pain on left side followed. Face felt 'droopy' and speech was slurred. Eyes red. She was nauseous and semi-conscious. She was seen in the emergency room.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: Within 6 hours of receiving the vaccine, patient experienced pain, redness, warmth at injection site. Left arm was painful and tingled and then spread to her left neck, face and head. Back pain on left side followed. Face felt 'droopy' and speech was slurred. Eyes red. She was nauseous and semi-conscious. She was seen in the emergency room.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Insomnia, Mental fatigue
Clinical narrative: Chills, body ache, extremely tender arm, tiredness, insomnia, mental fatigue, weakness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: Chills, body ache, extremely tender arm, tiredness, insomnia, mental fatigue, weakness.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Rash
Clinical narrative: REDNESS RASH AND SMALL KNOT IN ARM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling hot, Injection site pain, Oral mucosal eruption
Clinical narrative: Dizziness, achy at injection site, total body aches, chills, hot spells, break out on mouth.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Dizziness, achy at injection site, total body aches, chills, hot spells, break out on mouth.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Paraesthesia
Clinical narrative: Tingling, pain, burning, prodromal-like on left cheek from cheekbone to ear to eye and left nostril. Started morning of 3/24 and stopped afternoon of 3/2/18. Ice was only mildly effective in that it numbed but did not stop the sensation.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-AUG-2011, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. In May 2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about May 2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Co-suspect drug included sterile diluent (manufacturer unknown). The nurse reported a patient was inadvertently administered ZOSTAVAX (lot: N025703, expiry date: 16-DEC-2018) reconstituted with a sterile diluent (manufacturer unknown) by the intramuscular route instead of subcutaneous on 22-MAR-2018. No adverse effects were reported.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Immediate post-injection reaction, Pain, Tremor
Clinical narrative: Patient reported feeling severe chills, shaking, warmth and aching the evening immediately following vaccination. This was more intense than the mild to moderate aching she experienced following Shingrix #1. She dosed 2 extra strength TYLENOL tablets which provided relief. Following morning symptoms largely improved, but continues to dose TYLENOL q6h.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Injection site pain, Periarthritis
Clinical narrative: Onset of L shoulder pain over the course of several days following injection and progressive over several weeks. 3weeks after injection, evaluated of orthopedic surgeon and diagnosed with subacromial bursitis and early "frozen shoulder". Treated with steroid injection and physical therapy.  Continued to worsen....3-4months after injection pain was resolving per employee. She did not request time off work or restriction.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt called on 2-3-18 indicating a swollen, warm, itching, and painful area at the site of injection. She states it start a couple of hours after injection. Advised pt to take ibuprofen, BENADRYL and cold therapy at the site. Followed up w/pt on 2-5-18 for which she confirms the pain and swelling has resolved with ibuprofen. Advised pt to continue therapy and contact RX or MD should symptoms worsen and do not get better.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Influenza virus test negative, Injection site erythema, Pyrexia, Vaccination site inflammation
Clinical narrative: SHINGRIX was administered on 3/13/18. On 3/14/18, she ran fever of 102.5 degrees F, pulse 140, Respiratory rate of 30 with other vital sigs within normal limits. She also had a non-productive cough.  There was a "bulls-eye" type red, inflamed area on her upper left arm where the vaccine was administered. She is non-verbal and unable to give a report of pain. Acetaminophen was given for the fever and possible pain. It was effective and the fever subsided within 24 hours with no further intervention.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Loss of personal independence in daily activities, Nausea
Clinical narrative: Extreme shivering 12 hours after vaccine (duration 4 hours); Ache at site of injection; All over body aches; Bad headache; Slight nausea; Woke up morning of 3/23/2018 drenched in sweat, symptoms dissipated after that except for a mild lingering headache the rest of the day. Received vaccine on Thursday afternoon and had to miss work on Friday.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Extreme shivering 12 hours after vaccine (duration 4 hours); Ache at site of injection; All over body aches; Bad headache; Slight nausea; Woke up morning of 3/23/2018 drenched in sweat, symptoms dissipated after that except for a mild lingering headache the rest of the day. Received vaccine on Thursday afternoon and had to miss work on Friday.