chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Seizure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of seizure in a 63-year-old female patient who received BOOSTRIX (batch number 2E9JG, expiry date 8th October 2017). On 3rd December 2015, the patient received BOOSTRIX. On 8th December 2015, 5 days after receiving BOOSTRIX, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). In December 2015, the patient experienced brain edema (serious criteria hospitalization and GSK medically significant) and cerebrospinal fluid protein increased (serious criteria hospitalization and GSK medically significant). The patient was treated with KEPPRA. On an unknown date, the outcome of the seizure, brain edema and cerebrospinal fluid protein increased were recovering/resolving. It was unknown if the reporter considered the seizure, brain edema and cerebrospinal fluid protein increased to be related to BOOSTRIX. Additional details were provided as follows: The patient had no past medical history of seizures. The patient experienced a seizure while driving which resulted in a car accident. The patient was taken to the emergency room and was admitted for an unknown period of time. The reporter additionally reported that the patient experienced edema of the brain, described as swelling of the temporal lobes diagnosed by nuclear magnetic resonance imaging (MRI) on 24th December 2015 and elevated protein in the patient's cerebrospinal fluid (45 mg). All other blood work was normal. On 3rd May 2016, the patient had a repeat MRI and the swelling was resolving. The reported batch number for BOOSTRIX (ZE9JG) does not exist and was updated to 2E9JG as per the sales database.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Activities of daily living impaired, Angiogram, Blood test, Chest X-ray normal, Computerised tomogram
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Computerised tomogram head, Dizziness, Dysstasia, Electrocardiogram, Electroencephalogram normal
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Electronystagmogram, Fall, Monomelic amyotrophy, Musculoskeletal pain, Nerve conduction studies
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain, Paralysis
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Ultrasound scan, Vertigo, X-ray
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Neuralgic amyotrophy, Paralysis
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Carpal tunnel syndrome, Condition aggravated, Dizziness, Dysarthria, Grip strength decreased
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Headache, Hypoaesthesia, Mobility decreased, Monoparesis, Muscle twitching
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Muscular weakness, Musculoskeletal disorder, Musculoskeletal pain, Neuralgia, Neuralgic amyotrophy
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Neurological examination normal, Pain in extremity, Paraesthesia, Radiculitis brachial, Syncope
Clinical narrative: Initial unsolicited report received from a consumer on 06-May-2016. This case involves a female patient who was vaccinated with a dose of FLUZONE (batch number: U1836AA, expiration date: 30-Jun-2006) via intramuscular route in left deltoid on 20-Oct-2005. Patient had medical history of vertigo which was diagnosed on 18-Oct-2005. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 20-Oct-2005, same day immediately following the vaccination, the patient had left shoulder pain and diagnosed with Parsonage Turner Syndrome. On 21-Nov-2005, 32 days after the vaccination, patient left fingers were paralyzed. It was reported that patient required ER/Doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported for left shoulder pain and paralysis while it was reported that Parsonage Turner Syndrome was still present at the time of reporting. Upon internal review, the case was considered to be serious due to important medical events: Parsonage Turner Syndrome, Left shoulder pain and fingers were paralyzed. List of documents held by sender: none. Sender's Comments: Parsonage Turner Syndrome is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13, FLUX
Symptoms: Asthenia, Blood test, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: Initial unsolicited report received from a consumer (Pfizer courtesy report) on 14 March 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu Shot and a dose of PNEUMOCOCCAL VACCINE (Pr 13 Pneumonia Shot) for pneumonia (batch number, expiration date, site and route of administration were not reported for both vaccines) both on 04 December 2015. The patient had a medical history was not reported. Patient's other medical conditions included blood pressure (under control). Concomitant medications were reported as none. On an unspecified date, following the vaccination, the patient was allergic to everything in the book, had a hard time on it. Patient had to go emergency room because she had dehydration for which she was given some fluids, had no energy and no appetite. It was reported that the patient had experienced all side effects and thinks too many toxins were there in her body at one time. It was reported that she was not Hospice. It was reported that the patient was previously administered a dose of Flu Shot in September 2015 after which she really had a hard time on it and she had a lot of allergies. Lab data included the regular 90 day blood work for which results were not available. It was reported that they perform blood work whenever she had dehydration, as she had a whole week diarrhea. Patient required ER/ Doctor's visit. The patient received corrective treatment with some fluids for dehydration during emergency room visit. Patient was completely recovered from all the events on unspecified date. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13, FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a consumer (Pfizer courtesy report) on 14 March 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu Shot and a dose of PNEUMOCOCCAL VACCINE (Pr 13 Pneumonia Shot) for pneumonia (batch number, expiration date, site and route of administration were not reported for both vaccines) both on 04 December 2015. The patient had a medical history was not reported. Patient's other medical conditions included blood pressure (under control). Concomitant medications were reported as none. On an unspecified date, following the vaccination, the patient was allergic to everything in the book, had a hard time on it. Patient had to go emergency room because she had dehydration for which she was given some fluids, had no energy and no appetite. It was reported that the patient had experienced all side effects and thinks too many toxins were there in her body at one time. It was reported that she was not Hospice. It was reported that the patient was previously administered a dose of Flu Shot in September 2015 after which she really had a hard time on it and she had a lot of allergies. Lab data included the regular 90 day blood work for which results were not available. It was reported that they perform blood work whenever she had dehydration, as she had a whole week diarrhea. Patient required ER/ Doctor's visit. The patient received corrective treatment with some fluids for dehydration during emergency room visit. Patient was completely recovered from all the events on unspecified date. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13, FLUX
Symptoms: Blood pressure abnormal
Clinical narrative: Initial unsolicited report received from a consumer (Pfizer courtesy report) on 14 March 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu Shot and a dose of PNEUMOCOCCAL VACCINE (Pr 13 Pneumonia Shot) for pneumonia (batch number, expiration date, site and route of administration were not reported for both vaccines) both on 04 December 2015. The patient had a medical history was not reported. Patient's other medical conditions included blood pressure (under control). Concomitant medications were reported as none. On an unspecified date, following the vaccination, the patient was allergic to everything in the book, had a hard time on it. Patient had to go emergency room because she had dehydration for which she was given some fluids, had no energy and no appetite. It was reported that the patient had experienced all side effects and thinks too many toxins were there in her body at one time. It was reported that she was not Hospice. It was reported that the patient was previously administered a dose of Flu Shot in September 2015 after which she really had a hard time on it and she had a lot of allergies. Lab data included the regular 90 day blood work for which results were not available. It was reported that they perform blood work whenever she had dehydration, as she had a whole week diarrhea. Patient required ER/ Doctor's visit. The patient received corrective treatment with some fluids for dehydration during emergency room visit. Patient was completely recovered from all the events on unspecified date. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Influenza like illness, Pyrexia, Skin lesion
Clinical narrative: Pt developed fever and rash all over the entire body including limbs pt went to ER was treated with antifungals and steroids, creams etc.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Pt developed fever and rash all over the entire body including limbs pt went to ER was treated with antifungals and steroids, creams etc.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse refers to a 25 year old pregnant female patient with Last Menstrual Period (LMP) of 10-NOV-2015. The patient presented no pertinent medical history or drug allergies/reactions additionally, no concomitant medications were reported. On 06-JAN-2016 the patient was 8 weeks pregnant, first trimester when she was vaccinated with the second dose of GARADASIL 9 (lot # L028083 with expiry date 03-SEP-2017) (strength, dose, anatomical site and route were not reported). The patient did not seek any medical attention and none diagnostic studies were performed. Estimated Delivery Date (EDD) reported as 16-AUG-2016, however, it was unknown whether the patients were pregnant on the time of reporting. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Decreased appetite, Injection site movement impairment, Pain
Clinical narrative: He couldn't move his leg where he got the injection on. I had to hold him for 2 days. He hurt him too much to move it. He also developed a 103.4 tempature that evening. It continued and went to 104.8 that Friday the 05/13/2016. I had to take him in the ER for a fluid IV. He wasn't drinking or eating those 5 days. Medicine didn't help but it finally went down 05/16/2016.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Immobile, Injection site pain, Pyrexia, Swelling
Clinical narrative: Pain at site, swelling, immobility and fever for 2 days reported by patient.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Intervertebral disc protrusion, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Symptoms - Shoulder pain, neck pain, cervical herniated disk. Time course - 9/16/2015 to present. Treatments - cortisone, physical therapy, muscle relaxers (orphenadrine citrate).
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Allergy to vaccine, Excoriation, Laboratory test normal, Oropharyngeal pain
Clinical narrative: Initial unsolicited report received from a nurse on 21 March 2016. This case involves a 25 years male patient who was vaccinated with a dose of ADACEL (batch number U5298AA, expiration date, site of administration was not reported), intramuscularly on 01 February 2016. The patient's medical history and concomitant medications were not reported. On 02 February 2016, one day following the vaccination, the patient had broke out in a rash and it was stated as generalized rash noted over the patient's arms, chest, back, and hips. Lab data and corrective treatments were not reported. The outcome of event was not reported. Follow up information received from nurse 03 May 2016. It was reported that patient received 0.5 ml dose of ADACEL "Tdap" (expiration date 27 March 2018) intramuscularly in right deltoid on 1 February 2016. The patient had a medical history of eczema, smoker (0.25 packs per day for 4 years) quit from 01 November 2015, had alcohol use of 1.2 oz/week and no known allergy. Patient family history included, mother had lung cancer (non-small cell, non-smoker, age of onset 50) and maternal grandmother had diabetes mellitus (obesity), heart disease and hypertension. On an unspecified date, following vaccination patient developed Streptococcal pharyngitis, sore throat, stomach ache and allergy "Tdap listed as allergy". Laboratory data included POC rapid strep test which was positive, temperature (36.9 degree Celsius) and Saturation of Peripheral Oxygen (SpO2) was 98 %. Other Laboratory data included blood pressure (128/70 mmHg), pulse 87, eyes (Pupils Equal, Round, Reactive to Light, extraocular muscle), sexually transmitted infection (STI) screening was negative, ENT (MMM, oropharynx with bilaterally tonsillar erythema without edema or exudates), Neck (full range of motion, no thyromegaly, no palpable lymph nodes), Chest (clear to auscultation bilaterally, no wheezes), heart (regular rate and rhythms, no murmurs) and dermatology test included fine moderately erythematous popular rash over erythematous patches, worst over the flexor surfaces of the elbows and lower back, upper buttocks with associated excoriations, also involves upper back, abdomen and lateral hips and no sand paper texture. STI screening was negative and O positive blood type. The patient received corrective treatment with CLARITIN, BENADRYL (25-50 mg) every 6 hours for itching and rash, hydrocortisone(1%) cream up to three times daily over itchiest area, VEETIDS 1 tablet (500 mg total two times a day for 10 days) and for conservative management for symptoms gargling and ibuprofen. Outcome of events was not reported. List of documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Pharyngeal erythema, Pharyngitis streptococcal, Pruritus, Rash generalised, Rash papular
Clinical narrative: Initial unsolicited report received from a nurse on 21 March 2016. This case involves a 25 years male patient who was vaccinated with a dose of ADACEL (batch number U5298AA, expiration date, site of administration was not reported), intramuscularly on 01 February 2016. The patient's medical history and concomitant medications were not reported. On 02 February 2016, one day following the vaccination, the patient had broke out in a rash and it was stated as generalized rash noted over the patient's arms, chest, back, and hips. Lab data and corrective treatments were not reported. The outcome of event was not reported. Follow up information received from nurse 03 May 2016. It was reported that patient received 0.5 ml dose of ADACEL "Tdap" (expiration date 27 March 2018) intramuscularly in right deltoid on 1 February 2016. The patient had a medical history of eczema, smoker (0.25 packs per day for 4 years) quit from 01 November 2015, had alcohol use of 1.2 oz/week and no known allergy. Patient family history included, mother had lung cancer (non-small cell, non-smoker, age of onset 50) and maternal grandmother had diabetes mellitus (obesity), heart disease and hypertension. On an unspecified date, following vaccination patient developed Streptococcal pharyngitis, sore throat, stomach ache and allergy "Tdap listed as allergy". Laboratory data included POC rapid strep test which was positive, temperature (36.9 degree Celsius) and Saturation of Peripheral Oxygen (SpO2) was 98 %. Other Laboratory data included blood pressure (128/70 mmHg), pulse 87, eyes (Pupils Equal, Round, Reactive to Light, extraocular muscle), sexually transmitted infection (STI) screening was negative, ENT (MMM, oropharynx with bilaterally tonsillar erythema without edema or exudates), Neck (full range of motion, no thyromegaly, no palpable lymph nodes), Chest (clear to auscultation bilaterally, no wheezes), heart (regular rate and rhythms, no murmurs) and dermatology test included fine moderately erythematous popular rash over erythematous patches, worst over the flexor surfaces of the elbows and lower back, upper buttocks with associated excoriations, also involves upper back, abdomen and lateral hips and no sand paper texture. STI screening was negative and O positive blood type. The patient received corrective treatment with CLARITIN, BENADRYL (25-50 mg) every 6 hours for itching and rash, hydrocortisone(1%) cream up to three times daily over itchiest area, VEETIDS 1 tablet (500 mg total two times a day for 10 days) and for conservative management for symptoms gargling and ibuprofen. Outcome of events was not reported. List of documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Streptococcus test positive
Clinical narrative: Initial unsolicited report received from a nurse on 21 March 2016. This case involves a 25 years male patient who was vaccinated with a dose of ADACEL (batch number U5298AA, expiration date, site of administration was not reported), intramuscularly on 01 February 2016. The patient's medical history and concomitant medications were not reported. On 02 February 2016, one day following the vaccination, the patient had broke out in a rash and it was stated as generalized rash noted over the patient's arms, chest, back, and hips. Lab data and corrective treatments were not reported. The outcome of event was not reported. Follow up information received from nurse 03 May 2016. It was reported that patient received 0.5 ml dose of ADACEL "Tdap" (expiration date 27 March 2018) intramuscularly in right deltoid on 1 February 2016. The patient had a medical history of eczema, smoker (0.25 packs per day for 4 years) quit from 01 November 2015, had alcohol use of 1.2 oz/week and no known allergy. Patient family history included, mother had lung cancer (non-small cell, non-smoker, age of onset 50) and maternal grandmother had diabetes mellitus (obesity), heart disease and hypertension. On an unspecified date, following vaccination patient developed Streptococcal pharyngitis, sore throat, stomach ache and allergy "Tdap listed as allergy". Laboratory data included POC rapid strep test which was positive, temperature (36.9 degree Celsius) and Saturation of Peripheral Oxygen (SpO2) was 98 %. Other Laboratory data included blood pressure (128/70 mmHg), pulse 87, eyes (Pupils Equal, Round, Reactive to Light, extraocular muscle), sexually transmitted infection (STI) screening was negative, ENT (MMM, oropharynx with bilaterally tonsillar erythema without edema or exudates), Neck (full range of motion, no thyromegaly, no palpable lymph nodes), Chest (clear to auscultation bilaterally, no wheezes), heart (regular rate and rhythms, no murmurs) and dermatology test included fine moderately erythematous popular rash over erythematous patches, worst over the flexor surfaces of the elbows and lower back, upper buttocks with associated excoriations, also involves upper back, abdomen and lateral hips and no sand paper texture. STI screening was negative and O positive blood type. The patient received corrective treatment with CLARITIN, BENADRYL (25-50 mg) every 6 hours for itching and rash, hydrocortisone(1%) cream up to three times daily over itchiest area, VEETIDS 1 tablet (500 mg total two times a day for 10 days) and for conservative management for symptoms gargling and ibuprofen. Outcome of events was not reported. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial unsolicited misuse report received from a consumer on 4 May 2016. This case involves a 12-year-old female patient who was vaccinated with a dose of DAPTACEL instead of ADACEL intramuscularly in the right deltoid on 3 May 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported none and concomitant medications were not reported. On 3 May 2016. Same day following the vaccination, the patient had developed injection site lump (about 3 inches) which started swollen and sore to touch, patient stated that there was sore with arm movement. It was a case of wrong vaccine administered, inappropriate age at vaccine administration and product use in unapproved population. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was reported as not recovered. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product use issue, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a consumer on 4 May 2016. This case involves a 12-year-old female patient who was vaccinated with a dose of DAPTACEL instead of ADACEL intramuscularly in the right deltoid on 3 May 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported none and concomitant medications were not reported. On 3 May 2016. Same day following the vaccination, the patient had developed injection site lump (about 3 inches) which started swollen and sore to touch, patient stated that there was sore with arm movement. It was a case of wrong vaccine administered, inappropriate age at vaccine administration and product use in unapproved population. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was reported as not recovered. List of documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Per pt had "local reaction at injection site 4x6 cm area of redness and was painful to touch." Per pt used topical aloe with relief.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Eye patch application, Eyelid function disorder, Facial paralysis
Clinical narrative: This spontaneous report was received from a 60 year old male physician (also the patient) via company representative. The patient's medical history included episodes of shingles and Bell's Palsy in the past years (dates unspecified). On an unknown date in November 2015, the physician who is also the patient was vaccinated with ZOSTAVAX (dosage information, therapy route and lot number were not reported) for vaccination. Concomitant medications were not reported. On an unknown date in March 2016, the patient started showing signs of Bell's Palsy. The patient could not blink the left eye and hence a patch was placed over left eye to protect the eye. On an unknown date, the patient received unspecified antivirals and steroids as treatment. The patient sought medical attention by visiting physician's office. The reporter stated that there was intervention done to prevent serious criteria (details reported as Patch over left eye to protect eye because he could not blink). The outcome of Bell's Palsy was unknown. Causality assessment was not provided. No other information was available. Upon internal review the event "Bell's Palsy" was determined to be medically significant. Additional information has been requested.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site nodule
Clinical narrative: Pt has knot on right leg where PEDIARIX vaccine was given and has been there for almost 2 weeks. Pts mother has tried alternating ice and heat with no relief.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Inappropriate schedule of drug administration, Injection site nodule
Clinical narrative: Pt has knot on right leg where PEDIARIX vaccine was given and has been there for almost 2 weeks. Pts mother has tried alternating ice and heat with no relief.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Asthenia, Diarrhoea, Fatigue, Hypophagia, Nausea
Clinical narrative: Pt. mom called today stating that pt. has been sick since Wednesday with weakness, tiredness, diarrhea, nausea, not eating and 7 pound weight loss. I encouraged her to see her doctor ASAP. He father is a urologist and is treating with gatorade and immodium. I recommended lab and stool workup asap. Mom was thankful for call. Dr. notified VAERS report done.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Weight decreased
Clinical narrative: Pt. mom called today stating that pt. has been sick since Wednesday with weakness, tiredness, diarrhea, nausea, not eating and 7 pound weight loss. I encouraged her to see her doctor ASAP. He father is a urologist and is treating with gatorade and immodium. I recommended lab and stool workup asap. Mom was thankful for call. Dr. notified VAERS report done.
Age: 16.0
Sex: M
Vaccine: HEPA, IPV, MMR, MNQ, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever on Sunday 5/15/16 and rash started 5/16/16 on feet and legs and then 5/17/16 on hands and arms.
Age: 30.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Incorrect route of drug administration, Injection site reaction, Injection site swelling, Urticaria, Wrong drug administered
Clinical narrative: Initial unsolicited misuse case received from a non-healthcare professional (Social media) on 19 March 2016. Case was linked to 2016SA068811 (same reporter, vaccine and source). This case involves a 30 years old female patient who was vaccinated with a dose of Flu Vaccine (batch number, expiry date and route of administration were not reported) in hand (poked it) instead of TUBERSOL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Hours later I was informed that they had somehow mixed up the vials throughout the day and the nurse had injected me with the influenza instead of TB under my skin. Patient medical history and concomitant medications were not reported. It was reported that patient had taken TB tests before but stated that experience with her nurse on the day of vaccination was unusual. On an unspecified date, after vaccination patient experienced injection site swelling which began to welt up. It was a case of wrong vaccine administered and wrong route of administration. Lab tests and corrective treatments were not reported. Outcome of the events were not reported. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Incorrect route of drug administration, Injection site swelling, Injection site urticaria, Wrong drug administered
Clinical narrative: Initial unsolicited misuse case received from a non-healthcare professional (Social media) on 19 March 2016. Case was linked to 2016SA068811 (same reporter, vaccine and source). This case involves a 30 years old female patient who was vaccinated with a dose of Flu Vaccine (batch number, expiry date and route of administration were not reported) in hand (poked it) instead of TUBERSOL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Hours later I was informed that they had somehow mixed up the vials throughout the day and the nurse had injected me with the influenza instead of TB under my skin. Patient medical history and concomitant medications were not reported. It was reported that patient had taken TB tests before but stated that experience with her nurse on the day of vaccination was unusual. On an unspecified date, after vaccination patient experienced injection site swelling which began to welt up. It was a case of wrong vaccine administered and wrong route of administration. Lab tests and corrective treatments were not reported. Outcome of the events were not reported. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: PPV, TD, TDAP
Symptoms: Allergy to vaccine, Swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016009819) on 06-Apr-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) and a dose of DIPHTHERIA AND TETANUS TOXOIDS (Tetanus and Diphtheria Tox, Adult) (batch number, expiry date, route and site of administration: not reported for both vaccines) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy to vaccinations. On an unspecified date, after Tetanus and Diphtheria Tox, Adult vaccine, the patient developed swelling and on an unspecified date after TDAP vaccination the patient developed redness. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from other non-health care professional on 13 April 2016. This case is linked with case 2016SA074938 (same reporter, same lot number) and case 2016SA074966 (same reporter). This case involves a 51-year-old female patient who was vaccinated with a dose of ADACEL (Batch number: U5288BA, expiration date: 30 March 2018, dose number, route and site of administration were not reported) on 08 April 2016. Patient's medical history and concomitant medication were not reported. On 09 April 2016, one day post vaccination, the patient had experienced sore arm that she could not lift it and was swollen and red. Laboratory investigations and corrective treatment were not reported. The outcome of the events were not reported. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Welts on face.
Age: 56.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Erythema, Rash
Clinical narrative: Infant broke out in fine rash and erythema on face and torso 1 min after administering Rotateq vaccine. Provider notified immediately. No treatment required.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain surrounding injection site. Induration of about the size of a quarter. Pain and swelling lasted  x 10 days and resolved without treatment.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hot flush, Insomnia, Peripheral swelling
Clinical narrative: Swelling from elbow to arm pit. Headache. Severe hot flashes followed by chills. All on going five weeks later.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, CSF virus no organisms observed, Computerised tomogram head normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: 5-10-16 seizure, taken to ED via ambulance, admitted to ICU. Inpatient for approx. 48 hrs, discharged to home. Unknown etiology for seizure activity. Currently on KEPPRA until 2 yr of age. Dx prolonged seizure in a 4 mo previously healthy, developmentally normal female.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intensive care, Lumbar puncture, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Seizure
Clinical narrative: 5-10-16 seizure, taken to ED via ambulance, admitted to ICU. Inpatient for approx. 48 hrs, discharged to home. Unknown etiology for seizure activity. Currently on KEPPRA until 2 yr of age. Dx prolonged seizure in a 4 mo previously healthy, developmentally normal female.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Felt severe, sharp lateral shoulder pain during administration of influenza vaccine in right deltoid muscle. Pain worsened over next 6-8 weeks, but then slightly decreased. However, it is still present at this time.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Immediate pain upon withdrawal of needle (given high on arm) then sore for a couple of hours with increasing pain noted and limited ROM/mobility. Have had pain for 6+ months now. Have seen MD, PT, X-rays, MRI. Doing PT @ home presently. Never had pain in arm until after vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Immediate pain upon withdrawal of needle (given high on arm) then sore for a couple of hours with increasing pain noted and limited ROM/mobility. Have had pain for 6+ months now. Have seen MD, PT, X-rays, MRI. Doing PT @ home presently. Never had pain in arm until after vaccine.