chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Acute disseminated encephalomyelitis, Asthenia, Balance disorder, Brain scan normal
Clinical narrative: Initial unsolicited report received from a consumer (Patient's parent) on 27-Jan-2017. This case involves a five-year-old male patient who was vaccinated with a fifth dose of Fluzone Quadrivalent (batch number, expiry date, dose form frequency and site of administration not reported) via intramuscular route on 15-Sep-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were unknown. Illness at time of vaccination was none. Concomitant medications were not reported. Any other vaccines with four weeks of vaccination were not reported. On 03-Oct-2016, 18 days following the vaccination, the patient's mother reported that the patient complained of neck pain and later was sleeping following which he could not walk and vomited. The patient could not hold his  falls before he could walk. The patient was seen by a neurologist and had Magnetic resonance imaging (MRI) done and the subsequent diagnosis was Acute disseminated encephalomyelitis (ADEM). The patient had a seizure there with eyes going back and forth. The patient was hospitalized on an unspecified date for therapy and was in hospital for 40 days. Later the patient could walk with poor balance and core strength and his right arm was not moving fully and here were lesions in his spinal cord. The patient required ER visit. The patient was previously vaccinated with four doses of Fluzone on unspecified dates. On an unspecified date X-ray of collar bone was carried out. Brain scan was done on an unspecified date as well as a test for meningitis which was revealed as negative. The patient received medication (unspecified) for vomiting. The patient was put on Electroencephalography (EEG) and received steroids. The patient had not recovered from the events. List of documents held by the sender: None. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM) with associated symptoms, following FLUZONE VACCINE. Patient was had swelling overhead due fall details regarding it is needed, patient also had lesion in spinal cord. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Central nervous system lesion, Electroencephalogram, Eye movement disorder, Fall, Mobility decreased
Clinical narrative: Initial unsolicited report received from a consumer (Patient's parent) on 27-Jan-2017. This case involves a five-year-old male patient who was vaccinated with a fifth dose of Fluzone Quadrivalent (batch number, expiry date, dose form frequency and site of administration not reported) via intramuscular route on 15-Sep-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were unknown. Illness at time of vaccination was none. Concomitant medications were not reported. Any other vaccines with four weeks of vaccination were not reported. On 03-Oct-2016, 18 days following the vaccination, the patient's mother reported that the patient complained of neck pain and later was sleeping following which he could not walk and vomited. The patient could not hold his  falls before he could walk. The patient was seen by a neurologist and had Magnetic resonance imaging (MRI) done and the subsequent diagnosis was Acute disseminated encephalomyelitis (ADEM). The patient had a seizure there with eyes going back and forth. The patient was hospitalized on an unspecified date for therapy and was in hospital for 40 days. Later the patient could walk with poor balance and core strength and his right arm was not moving fully and here were lesions in his spinal cord. The patient required ER visit. The patient was previously vaccinated with four doses of Fluzone on unspecified dates. On an unspecified date X-ray of collar bone was carried out. Brain scan was done on an unspecified date as well as a test for meningitis which was revealed as negative. The patient received medication (unspecified) for vomiting. The patient was put on Electroencephalography (EEG) and received steroids. The patient had not recovered from the events. List of documents held by the sender: None. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM) with associated symptoms, following FLUZONE VACCINE. Patient was had swelling overhead due fall details regarding it is needed, patient also had lesion in spinal cord. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Nuclear magnetic resonance imaging abnormal, Seizure, Swelling, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (Patient's parent) on 27-Jan-2017. This case involves a five-year-old male patient who was vaccinated with a fifth dose of Fluzone Quadrivalent (batch number, expiry date, dose form frequency and site of administration not reported) via intramuscular route on 15-Sep-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were unknown. Illness at time of vaccination was none. Concomitant medications were not reported. Any other vaccines with four weeks of vaccination were not reported. On 03-Oct-2016, 18 days following the vaccination, the patient's mother reported that the patient complained of neck pain and later was sleeping following which he could not walk and vomited. The patient could not hold his  falls before he could walk. The patient was seen by a neurologist and had Magnetic resonance imaging (MRI) done and the subsequent diagnosis was Acute disseminated encephalomyelitis (ADEM). The patient had a seizure there with eyes going back and forth. The patient was hospitalized on an unspecified date for therapy and was in hospital for 40 days. Later the patient could walk with poor balance and core strength and his right arm was not moving fully and here were lesions in his spinal cord. The patient required ER visit. The patient was previously vaccinated with four doses of Fluzone on unspecified dates. On an unspecified date X-ray of collar bone was carried out. Brain scan was done on an unspecified date as well as a test for meningitis which was revealed as negative. The patient received medication (unspecified) for vomiting. The patient was put on Electroencephalography (EEG) and received steroids. The patient had not recovered from the events. List of documents held by the sender: None. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM) with associated symptoms, following FLUZONE VACCINE. Patient was had swelling overhead due fall details regarding it is needed, patient also had lesion in spinal cord. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Initial unsolicited report received from a consumer (Patient's parent) on 27-Jan-2017. This case involves a five-year-old male patient who was vaccinated with a fifth dose of Fluzone Quadrivalent (batch number, expiry date, dose form frequency and site of administration not reported) via intramuscular route on 15-Sep-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were unknown. Illness at time of vaccination was none. Concomitant medications were not reported. Any other vaccines with four weeks of vaccination were not reported. On 03-Oct-2016, 18 days following the vaccination, the patient's mother reported that the patient complained of neck pain and later was sleeping following which he could not walk and vomited. The patient could not hold his  falls before he could walk. The patient was seen by a neurologist and had Magnetic resonance imaging (MRI) done and the subsequent diagnosis was Acute disseminated encephalomyelitis (ADEM). The patient had a seizure there with eyes going back and forth. The patient was hospitalized on an unspecified date for therapy and was in hospital for 40 days. Later the patient could walk with poor balance and core strength and his right arm was not moving fully and here were lesions in his spinal cord. The patient required ER visit. The patient was previously vaccinated with four doses of Fluzone on unspecified dates. On an unspecified date X-ray of collar bone was carried out. Brain scan was done on an unspecified date as well as a test for meningitis which was revealed as negative. The patient received medication (unspecified) for vomiting. The patient was put on Electroencephalography (EEG) and received steroids. The patient had not recovered from the events. List of documents held by the sender: None. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis (ADEM) with associated symptoms, following FLUZONE VACCINE. Patient was had swelling overhead due fall details regarding it is needed, patient also had lesion in spinal cord. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Pain
Clinical narrative: Patient states the vaccine was given in a different area than the deltoid muscle. She had immediate pain and pain has persisted since then.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated she went home after the vaccine and took a nap. When she woke up her arm was very sore and difficult to move. She wanted to make sure this was reported.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Hypoaesthesia, Impaired work ability, Injection site pain, Mobility decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received FLUARIX QUADRIVALENT (batch number 23L7C, expiry date unknown). Previously administered products included flu vaccine (received in last year). On 9th January 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular). On 10th January 2017, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria hospitalization and disability). On 12th January 2017, the patient experienced mobility decreased (serious criteria hospitalization and disability), weakness of arms (serious criteria hospitalization and disability), numbness (serious criteria hospitalization and disability) and sleep disturbance. On an unknown date, the outcome of the injection site pain, mobility decreased, weakness of arms and numbness were recovering/resolving and the outcome of the sleep disturbance was unknown. The reporter considered the injection site pain, mobility decreased, weakness of arms and numbness to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the sleep disturbance to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by an Occupational Health Nurse with the disability Management group at GSK, who was notified via the phone, by another GSK employee (patient) he had a reaction to the GSK FLUARIX vaccine. The case was previously reported to a doctor. The patient informed the nurse on 1st June 2017 via telephone that he had initial soreness at the injection site on 10th January 2017. The patient accessed the emergency room. On 11th January 2017, it became pain that was severe in his right arm down to his elbow, across the back of his shoulder, neck and upper left shoulder and arm. On 12th January 2017, the pain worsened in the identified areas and extended on both sides of his lateral dorsi, impacting his sleep, limited ability to lift items more than 4 or 5 pounds with his arms and wrists, he also complained of numbness in his wrists. The patient had been unable to return to work. On 21st January 2017, he did note improvement in the symptoms, however limited mobility and weakness in his arms and wrists remained. It was also noted that the patient had received the flu vaccine in previous years, but unknown if it was FLUARIX. The patient had reported these events to his physician. At the time of reporting, the patient (employee) was on leave with GSK. The reported batch number (2317C) of FLUARIX QUADRIVALENT did not exist and was updated to 23L7C as per sales database.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal pain, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received FLUARIX QUADRIVALENT (batch number 23L7C, expiry date unknown). Previously administered products included flu vaccine (received in last year). On 9th January 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular). On 10th January 2017, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria hospitalization and disability). On 12th January 2017, the patient experienced mobility decreased (serious criteria hospitalization and disability), weakness of arms (serious criteria hospitalization and disability), numbness (serious criteria hospitalization and disability) and sleep disturbance. On an unknown date, the outcome of the injection site pain, mobility decreased, weakness of arms and numbness were recovering/resolving and the outcome of the sleep disturbance was unknown. The reporter considered the injection site pain, mobility decreased, weakness of arms and numbness to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the sleep disturbance to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by an Occupational Health Nurse with the disability Management group at GSK, who was notified via the phone, by another GSK employee (patient) he had a reaction to the GSK FLUARIX vaccine. The case was previously reported to a doctor. The patient informed the nurse on 1st June 2017 via telephone that he had initial soreness at the injection site on 10th January 2017. The patient accessed the emergency room. On 11th January 2017, it became pain that was severe in his right arm down to his elbow, across the back of his shoulder, neck and upper left shoulder and arm. On 12th January 2017, the pain worsened in the identified areas and extended on both sides of his lateral dorsi, impacting his sleep, limited ability to lift items more than 4 or 5 pounds with his arms and wrists, he also complained of numbness in his wrists. The patient had been unable to return to work. On 21st January 2017, he did note improvement in the symptoms, however limited mobility and weakness in his arms and wrists remained. It was also noted that the patient had received the flu vaccine in previous years, but unknown if it was FLUARIX. The patient had reported these events to his physician. At the time of reporting, the patient (employee) was on leave with GSK. The reported batch number (2317C) of FLUARIX QUADRIVALENT did not exist and was updated to 23L7C as per sales database.
Age: 1.83
Sex: M
Vaccine: HEP, IPV, PNC13
Symptoms: Cough, Dehydration, Pneumonia, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: Patient presented to ED 2-7-17-10:30-reported 2 days of fever, cough, runny nose and vomited once. Temp 100.3 Pulse 144, Respiration 36 BP 118/88. Admitted approximate 1:30 pm w/RSV-secondary pneumonia dehydration.
Age: 1.83
Sex: M
Vaccine: HEP, IPV, PNC13
Symptoms: Respiratory syncytial virus test positive, Rhinorrhoea, Vomiting
Clinical narrative: Patient presented to ED 2-7-17-10:30-reported 2 days of fever, cough, runny nose and vomited once. Temp 100.3 Pulse 144, Respiration 36 BP 118/88. Admitted approximate 1:30 pm w/RSV-secondary pneumonia dehydration.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Developed rash on abdomen, lower back and sides of torso on Monday 2/6/17. No treatment needed. Rash R/T PROQUAD (MMRV) Afebrile. No other symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a female physician of unknown age via a company representative referring to herself. The patient's pertinent medical history included type 2 diabetes. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot # and expiry date were not reported) to prevent shingles. On an unknown date (after she received  the ZOSTAVAX), the patient had gotten shingles. She prescribed herself unspecified antiviral drugs for treatment of the shingles. Action taken with ZOSTAVAX, the outcome of the event and the relatedness between the event and ZOSTAVAX were not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unspecified dates, the patients were vaccinated with VARIVAX (lot #: M025870 with expiration date: 24-MAY-2018, lot #: M010484 with expiration date: 01-MAR-2018 and lot #: M000757 with expiration date: 06-JAN-2018) (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 5°F but less than 14 °F for 48 hours and at temperature greater than 14°F but less than 46°F for 72 hours without any previous temperature excursion. No adverse effects were reported. Data logger was reported as No. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000248: US-009507513-1701USA013789.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unspecified dates, the patients were vaccinated with ZOSTAVAX (lot #: M015925 with expiration date: 15-JUN-2017 (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 5°F but less than 14 °F for 48 hours and at temperature greater than 14°F but less than 46°F for 72 hours without any previous temperature excursion. No adverse effects were reported. Data logger was reported as No. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013789: US-009507513-1702USA000247.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Dermatitis allergic, Diarrhoea, Frequent bowel movements, Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 15-month-old male patient who received INFANRIX (batch number 75H53, expiry date 27th September 2016). On 5th August 2014, the patient received the 4th dose of INFANRIX 0.5 ml. On 5th August 2014, less than a day after receiving INFANRIX, the patient experienced injection site rash, injection site urticaria, frequent bowel movements, loose stools and irritability. The patient was treated with Steroid (Not Specified). In 2014, the outcome of the injection site rash and injection site urticaria were recovered/resolved. On an unknown date, the outcome of the frequent bowel movements, loose stools and irritability were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site urticaria, frequent bowel movements, loose stools and irritability to be related to INFANRIX. Additional details were provided as follows: The mother of the patient called to check the batch number of vaccine. The patient had administration site rash which appeared as hives after receiving the vaccine that spread all over his injection leg, then spread to his other leg, then spread up his body. The only place that didn't get hives rash was on his face. The rash lasted between 4 and half and 5 weeks and which was treated with strong steroid prescription gel given by doctor, who was allergist. The mother reported the patient was bothered by the rash and had signs of irritability. The patient did not receive any other vaccines that date. When the patient received his MMR vaccination at age 2 and half, the doctor tested the patient prior with skin testing and the patient had mild reaction to the allergy testing of the MMR vaccine. The patient was administered the MMR but was treated before with BENADRYL or antihistamines. The vaccine was given in small amounts, taking several hours to fully administer. The allergist also tested the patient recently with skin tests using two different kinds of flu vaccine, FLUZONE and another preservative free flu vaccine, and the patient showed an allergic skin reaction to both of these vaccines. The reporter referred the mother to report the reaction. The mother and allergist were working together to try to pinpoint what the patient was reacting to.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Skin test positive, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 15-month-old male patient who received INFANRIX (batch number 75H53, expiry date 27th September 2016). On 5th August 2014, the patient received the 4th dose of INFANRIX 0.5 ml. On 5th August 2014, less than a day after receiving INFANRIX, the patient experienced injection site rash, injection site urticaria, frequent bowel movements, loose stools and irritability. The patient was treated with Steroid (Not Specified). In 2014, the outcome of the injection site rash and injection site urticaria were recovered/resolved. On an unknown date, the outcome of the frequent bowel movements, loose stools and irritability were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site urticaria, frequent bowel movements, loose stools and irritability to be related to INFANRIX. Additional details were provided as follows: The mother of the patient called to check the batch number of vaccine. The patient had administration site rash which appeared as hives after receiving the vaccine that spread all over his injection leg, then spread to his other leg, then spread up his body. The only place that didn't get hives rash was on his face. The rash lasted between 4 and half and 5 weeks and which was treated with strong steroid prescription gel given by doctor, who was allergist. The mother reported the patient was bothered by the rash and had signs of irritability. The patient did not receive any other vaccines that date. When the patient received his MMR vaccination at age 2 and half, the doctor tested the patient prior with skin testing and the patient had mild reaction to the allergy testing of the MMR vaccine. The patient was administered the MMR but was treated before with BENADRYL or antihistamines. The vaccine was given in small amounts, taking several hours to fully administer. The allergist also tested the patient recently with skin tests using two different kinds of flu vaccine, FLUZONE and another preservative free flu vaccine, and the patient showed an allergic skin reaction to both of these vaccines. The reporter referred the mother to report the reaction. The mother and allergist were working together to try to pinpoint what the patient was reacting to.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site discolouration, Injection site swelling, Injection site warmth
Clinical narrative: According to the patient the injection site swelled up, was very warm, and became discolored. The area was about the size of a soft ball in width. As of 2/3/17 the area is about 3 inches wide, circular, and discolored. It is not raised, painful, or itchy.
Age: 22.0
Sex: F
Vaccine: JEV1
Symptoms: Chest X-ray, Full blood count normal, Liver function test normal, Lymphadenopathy, Neck pain
Clinical narrative: 1/27 NECK SORE (RT SIDE) 1/28 RIGHT CERVICAL LYMPH NODE SWOLLEN SUNDAY - SWOLLEN RED BUMPS DIME & QUARTER SIZED & LARGER, UPPER & LOWER LEGS - SORE, NOT ITCHY.
Age: 22.0
Sex: F
Vaccine: JEV1
Symptoms: Rash, Rash erythematous, Red blood cell sedimentation rate increased, Renal function test normal, Tuberculin test
Clinical narrative: 1/27 NECK SORE (RT SIDE) 1/28 RIGHT CERVICAL LYMPH NODE SWOLLEN SUNDAY - SWOLLEN RED BUMPS DIME & QUARTER SIZED & LARGER, UPPER & LOWER LEGS - SORE, NOT ITCHY.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever of 103 and vomiting.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain, Back pain, CSF protein increased, Computerised tomogram normal, Facial pain
Clinical narrative: Numbness, in fingers and toe, within days progress to numbness, pain, tingling in hands, feet, back, face, and throat, continued to get progressively worse, unable to walk independently. 11-18-2016 - Diagnosis - GBS Treatment - IVIG.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Numbness, in fingers and toe, within days progress to numbness, pain, tingling in hands, feet, back, face, and throat, continued to get progressively worse, unable to walk independently. 11-18-2016 - Diagnosis - GBS Treatment - IVIG.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain in extremity, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Numbness, in fingers and toe, within days progress to numbness, pain, tingling in hands, feet, back, face, and throat, continued to get progressively worse, unable to walk independently. 11-18-2016 - Diagnosis - GBS Treatment - IVIG.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pharyngeal paraesthesia, Ultrasound scan normal
Clinical narrative: Numbness, in fingers and toe, within days progress to numbness, pain, tingling in hands, feet, back, face, and throat, continued to get progressively worse, unable to walk independently. 11-18-2016 - Diagnosis - GBS Treatment - IVIG.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Rash generalised, Rash pruritic
Clinical narrative: Pt developed an itchy, body rash immediately after vaccines were given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with doses of VARIVAX lot # M034583 (expiration date 27-JUL-2018) administered subcutaneously for prophylaxis (dose was not reported). The doses were stored at temperatures >14 degrees Fahrenheit and <46 degrees Fahrenheit (26.7 degrees Fahrenheit) for a total of 30 minutes as identified by a digital data logger. It was reported that there were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004183.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX lot # M035694 (expiration date 07-NOV-2017) and M0347694 (expiration date 26-OCT-2017) administered subcutaneously for prophylaxis (dose not reported). The doses were stored at temperatures > 14 degrees Fahrenheit and < 46 degrees Fahrenheit (26.7 degrees Fahrenheit) for a total of 30 minutes as identified by a digital data logger. It was reported that there were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. Lot number M0347694  is an invalid lot number for zoster vaccine live. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004169:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 10-JAN-2017 from a pharmacist via a consumer regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. The consumer reported that a pharmacist told her that on unknown date the unspecified female patient was vaccinated with ZOSTAVAX, (lot number and expiration not reported) unknown route for prophylaxis and later on an unknown date the patient developed shingles. The outcome of shingles is unknown.  No further information was reported. This is one of two reports from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB with lot # M037019 that has been verified to be valid, expiration date: 04-NOV-2018, via intramuscular, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 24 hours and between 32 and 36 Fahrenheit degrees for 419 hours and 30 minutes. There were no previous temperature excursions. Digital data logger was not involved. It was also reported that the patients were vaccinated with improperly stored doses of RECOMBIVAX HB via intramuscular as prophylaxis (Strength, dose, lot #, expiration date and dose were not reported), which experienced an unknown temperature excursion for an unknown time frame. There were no previous temperature excursions. Digital data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000283.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 15 year old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in June 2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). On an unspecified date in August 2016, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). On an unspecified date in September 2016, the patient was vaccinated with the third dose of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). It was stated that the third dose was given earlier that the recommended for GARDASIL 9 series. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-MAY-2013 and on 30-MAR-2016, the patient was vaccinated with the first and second dose of PROQUAD as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). On 25-JAN-2017, the patient was vaccinated with the third dose of PROQUAD lot # M033209, expiration date: 09-JAN-2018, as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site reaction, Rash erythematous
Clinical narrative: States that arm was numb then slowly resolved, but then the following day patient developed red spots/patches (some up to 5 inches long) along her shoulder on the left side (side of injection).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 82.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Arthritis reactive, Back pain, Bartonella test negative, Blood culture negative
Clinical narrative: Within an hour of vaccination, he experienced rapid onset discomfort in his left wrist, right arm, and shoulders. By the time he arrived home, he felt pain throughout his arms, hands, back, and legs and had significant difficulty moving due to the pain. He saw Rheumatology on 12/16 and was referred to the ED given the rapid onset of his multiple joint pains.  Admission was negative for infection. Migratory joint pains persisted for 5 weeks, requiring narcotics for pain relief, but ultimately resolved with steroid treatment (initially 40 mg followed by taper). Rheumatologist's ultimate diagnosis was a vaccine reaction/reactive arthritis/serum sickness like illness.
Age: 82.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Borrelia test negative, C-reactive protein increased, Chest X-ray normal, Computerised tomogram abdomen normal, Coxiella test
Clinical narrative: Within an hour of vaccination, he experienced rapid onset discomfort in his left wrist, right arm, and shoulders. By the time he arrived home, he felt pain throughout his arms, hands, back, and legs and had significant difficulty moving due to the pain. He saw Rheumatology on 12/16 and was referred to the ED given the rapid onset of his multiple joint pains.  Admission was negative for infection. Migratory joint pains persisted for 5 weeks, requiring narcotics for pain relief, but ultimately resolved with steroid treatment (initially 40 mg followed by taper). Rheumatologist's ultimate diagnosis was a vaccine reaction/reactive arthritis/serum sickness like illness.
Age: 82.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Hepatitis B test negative, Hepatitis C test negative, Injection site discomfort, Laboratory test normal, Limb discomfort
Clinical narrative: Within an hour of vaccination, he experienced rapid onset discomfort in his left wrist, right arm, and shoulders. By the time he arrived home, he felt pain throughout his arms, hands, back, and legs and had significant difficulty moving due to the pain. He saw Rheumatology on 12/16 and was referred to the ED given the rapid onset of his multiple joint pains.  Admission was negative for infection. Migratory joint pains persisted for 5 weeks, requiring narcotics for pain relief, but ultimately resolved with steroid treatment (initially 40 mg followed by taper). Rheumatologist's ultimate diagnosis was a vaccine reaction/reactive arthritis/serum sickness like illness.
Age: 82.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Mobility decreased, Musculoskeletal discomfort, Mycoplasma test negative, Pain, Pain in extremity
Clinical narrative: Within an hour of vaccination, he experienced rapid onset discomfort in his left wrist, right arm, and shoulders. By the time he arrived home, he felt pain throughout his arms, hands, back, and legs and had significant difficulty moving due to the pain. He saw Rheumatology on 12/16 and was referred to the ED given the rapid onset of his multiple joint pains.  Admission was negative for infection. Migratory joint pains persisted for 5 weeks, requiring narcotics for pain relief, but ultimately resolved with steroid treatment (initially 40 mg followed by taper). Rheumatologist's ultimate diagnosis was a vaccine reaction/reactive arthritis/serum sickness like illness.
Age: 82.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Parvovirus B19 test negative, Red blood cell sedimentation rate increased, Serum sickness-like reaction, Staphylococcus test negative, Synovial fluid white blood cells positive
Clinical narrative: Within an hour of vaccination, he experienced rapid onset discomfort in his left wrist, right arm, and shoulders. By the time he arrived home, he felt pain throughout his arms, hands, back, and legs and had significant difficulty moving due to the pain. He saw Rheumatology on 12/16 and was referred to the ED given the rapid onset of his multiple joint pains.  Admission was negative for infection. Migratory joint pains persisted for 5 weeks, requiring narcotics for pain relief, but ultimately resolved with steroid treatment (initially 40 mg followed by taper). Rheumatologist's ultimate diagnosis was a vaccine reaction/reactive arthritis/serum sickness like illness.
Age: 82.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Urine analysis normal, Vaccination complication, White blood cell count increased
Clinical narrative: Within an hour of vaccination, he experienced rapid onset discomfort in his left wrist, right arm, and shoulders. By the time he arrived home, he felt pain throughout his arms, hands, back, and legs and had significant difficulty moving due to the pain. He saw Rheumatology on 12/16 and was referred to the ED given the rapid onset of his multiple joint pains.  Admission was negative for infection. Migratory joint pains persisted for 5 weeks, requiring narcotics for pain relief, but ultimately resolved with steroid treatment (initially 40 mg followed by taper). Rheumatologist's ultimate diagnosis was a vaccine reaction/reactive arthritis/serum sickness like illness.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Erythema, Fall, Head injury
Clinical narrative: Patient stated that after she left the pharmacy she experienced redness and swelling from the shot area to her wrist, she also experienced fever. She also experienced dizziness and fell and hit head. Per patient she was diagnosed with cellulitis and been treated.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: Patient stated that after she left the pharmacy she experienced redness and swelling from the shot area to her wrist, she also experienced fever. She also experienced dizziness and fell and hit head. Per patient she was diagnosed with cellulitis and been treated.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Woke up and had really bad pain in right shoulder, couldn't lift arm, no swelling, and no red marks.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth, Muscle tightness, Pain in extremity
Clinical narrative: Tdap (Adacel) vaccine administered IM to right deltoid on 2/1/2017. On 02/03/2017, patient reported reaction at vaccination site. RN observed redness and warmth to right upper extremity above and to the right of injection site. Patient reported extremity soreness. Patient self-treated with ibuprofen and ice to site at reaction onset. RN reported reaction to clinic physician, secured appointment. Clinic physician prescribed Benadryl, recommended ice to site. On 02/06/2017, patient reported redness, warmth, soreness resolved. Small knot like raised area to affected extremity at or near injection site. Clinic physician advised heat to site and activity to affected extremity to ease muscle tension.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site reaction
Clinical narrative: Tdap (Adacel) vaccine administered IM to right deltoid on 2/1/2017. On 02/03/2017, patient reported reaction at vaccination site. RN observed redness and warmth to right upper extremity above and to the right of injection site. Patient reported extremity soreness. Patient self-treated with ibuprofen and ice to site at reaction onset. RN reported reaction to clinic physician, secured appointment. Clinic physician prescribed Benadryl, recommended ice to site. On 02/06/2017, patient reported redness, warmth, soreness resolved. Small knot like raised area to affected extremity at or near injection site. Clinic physician advised heat to site and activity to affected extremity to ease muscle tension.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria, Lymph node pain
Clinical narrative: Red raised welts & hives, localized within 4 inch radius of injection site. Very painful to touch but not itchy. Welts expanded and merged next 24 hours, but did not extend beyond 4 inches of injection site. Lymph nodes swollen & painful in upper arm, armpit & neck on same side as injection site. No difficulty breathing, so clinic recommended oral BENADRYL, and if not resolved within 4 days of initial injection, then return for further treatment.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: Red raised welts & hives, localized within 4 inch radius of injection site. Very painful to touch but not itchy. Welts expanded and merged next 24 hours, but did not extend beyond 4 inches of injection site. Lymph nodes swollen & painful in upper arm, armpit & neck on same side as injection site. No difficulty breathing, so clinic recommended oral BENADRYL, and if not resolved within 4 days of initial injection, then return for further treatment.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Red raised welts & hives, localized within 4 inch radius of injection site. Very painful to touch but not itchy. Welts expanded and merged next 24 hours, but did not extend beyond 4 inches of injection site. Lymph nodes swollen & painful in upper arm, armpit & neck on same side as injection site. No difficulty breathing, so clinic recommended oral BENADRYL, and if not resolved within 4 days of initial injection, then return for further treatment.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Neck pain, Urticaria
Clinical narrative: Red raised welts & hives, localized within 4 inch radius of injection site. Very painful to touch but not itchy. Welts expanded and merged next 24 hours, but did not extend beyond 4 inches of injection site. Lymph nodes swollen & painful in upper arm, armpit & neck on same side as injection site. No difficulty breathing, so clinic recommended oral BENADRYL, and if not resolved within 4 days of initial injection, then return for further treatment.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Pyrexia
Clinical narrative: I was very cold for about 3 hours, which is unusual for me, followed by several hours of fever.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Severe shoulder pain when extending arm.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Ear disorder, Enuresis, Incontinence, Middle insomnia, Thirst
Clinical narrative: Well potty trained started having accidents. Ear problems, constant thirst. Waking at night to drink water and incontinence.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Well potty trained started having accidents. Ear problems, constant thirst. Waking at night to drink water and incontinence.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injected limb mobility decreased, Injection site nodule, Injection site pain
Clinical narrative: PT REPORTS WAKING UP NEXT MORNING FOLLOWING VACCINATION WITH DIZZINESS AND LIGHTHEADEDNESS, WHICH PERSISTED THROUGHOUT THE DAY AND RESOLVED WITHIN 24 HOURS. ALSO REPORTED EXTREME INJECTION SITE PAIN AND LIMITED MOVEMENT OF RIGHT ARM WHERE INJECTION WAS ADMINISTERED IN RIGHT DELTOID. ALSO REPORTED "KNOT" AT INJECTION SITE, WHICH DID RESOLVE BY THE TIME OF REASSESSMENT, WHICH WAS 48 HOURS FOLLOWING TIME OF INJECTION.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Allergy test, Blood test, Chest X-ray, Dyspnoea
Clinical narrative: Throat Closing, trouble breathing - gave him asthma meds and albuterol breathing treatments - this continued for 2 weeks. Antibiotics and then Steroids for possible infection. Called 911 after an early morning throat closing/trouble breathing. Hospital tests run - possible acid reflux. Did allergy scratch test, barium test, ultrasounds on pelvis and bladder. Symptoms are still throat closing, seeming allergies to all foods, severe acid reflux. Severe stomach pains now and frequent urination. Taking ZANTAC, BENADRYL.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Food allergy, Gastrooesophageal reflux disease, Pollakiuria, Pulmonary function test, Stool analysis
Clinical narrative: Throat Closing, trouble breathing - gave him asthma meds and albuterol breathing treatments - this continued for 2 weeks. Antibiotics and then Steroids for possible infection. Called 911 after an early morning throat closing/trouble breathing. Hospital tests run - possible acid reflux. Did allergy scratch test, barium test, ultrasounds on pelvis and bladder. Symptoms are still throat closing, seeming allergies to all foods, severe acid reflux. Severe stomach pains now and frequent urination. Taking ZANTAC, BENADRYL.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Throat tightness, Ultrasound bladder, Ultrasound pelvis, Urine analysis, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Throat Closing, trouble breathing - gave him asthma meds and albuterol breathing treatments - this continued for 2 weeks. Antibiotics and then Steroids for possible infection. Called 911 after an early morning throat closing/trouble breathing. Hospital tests run - possible acid reflux. Did allergy scratch test, barium test, ultrasounds on pelvis and bladder. Symptoms are still throat closing, seeming allergies to all foods, severe acid reflux. Severe stomach pains now and frequent urination. Taking ZANTAC, BENADRYL.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reactions. Pharmacist called patient right away when realized the shot expired in 1.17.