chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Chest X-ray normal, Cough, Discomfort, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 75-year-old female patient received, on 15Jul2015, PREVNAR 13 single dose, in arm. Relevant medical history and concomitant medications were unknown. The patient yearly received Influenza vaccine, as well as unspecified pneumococcal vaccine and has never had an adverse reaction. The patient experienced the following adverse events: injection site swelling, black mark, red circle, burning (slight), all on an unknown date in Jul2015 (within hours from vaccination); chronic cough from 15Jul2015 until Dec2015 (treated with benzonatate 100 mg); severe bronchitis from 20Jul2015 to 30Sep2015 (treated with doxycycline 100 mg); trouble sleeping due to coughing; congestion, and shortness of breath from 22Jul2015; red injection site, immune system disorder, fatigue, malaise (she was not feeling well) and expelling excretions from an unspecified date. The consumer reported that at the injection site the arm swelled to three times normal site: a black mark dotted the flesh where the needle was injected: the site was encircled, bright red and burning to the touch. The doctor was notified and took measurements for swelling and redness and administered an antibiotic and a prescription for a 10 day regimen of cephalexin 500 mg. As of 09Dec2015 the consumer was still coughing hacking and expelling from nose and throat. The consumer underwent lung X-rays on 03Sep2015 and chest X-rays on 12Nov2015, both showing no problem with heart or lungs. The consumer felt the entire immune system was compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the consumer had not enjoyed a normal day of comfort, good health, or solid sleep due to coughing, expelling excretions and experiencing feelings of general fatigue and ill health. The patient recovered from the events, ecchymosis, rash macular, burning sensation, chronic cough, swelling arm, bronchitis, vaccination site erythema, vaccination site swelling. The patient did not recover from the events, congestion nasal, shortness of breath; while clinical outcome of the other events was unknown. Follow-up (11Apr2016): New information reported from the contactable consumer includes: patient details (gender provided), reaction data and case seriousness changed from non-serious to serious (hospitalization).
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Ecchymosis, Fatigue, Immune system disorder, Increased upper airway secretion, Injection site discolouration
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 75-year-old female patient received, on 15Jul2015, PREVNAR 13 single dose, in arm. Relevant medical history and concomitant medications were unknown. The patient yearly received Influenza vaccine, as well as unspecified pneumococcal vaccine and has never had an adverse reaction. The patient experienced the following adverse events: injection site swelling, black mark, red circle, burning (slight), all on an unknown date in Jul2015 (within hours from vaccination); chronic cough from 15Jul2015 until Dec2015 (treated with benzonatate 100 mg); severe bronchitis from 20Jul2015 to 30Sep2015 (treated with doxycycline 100 mg); trouble sleeping due to coughing; congestion, and shortness of breath from 22Jul2015; red injection site, immune system disorder, fatigue, malaise (she was not feeling well) and expelling excretions from an unspecified date. The consumer reported that at the injection site the arm swelled to three times normal site: a black mark dotted the flesh where the needle was injected: the site was encircled, bright red and burning to the touch. The doctor was notified and took measurements for swelling and redness and administered an antibiotic and a prescription for a 10 day regimen of cephalexin 500 mg. As of 09Dec2015 the consumer was still coughing hacking and expelling from nose and throat. The consumer underwent lung X-rays on 03Sep2015 and chest X-rays on 12Nov2015, both showing no problem with heart or lungs. The consumer felt the entire immune system was compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the consumer had not enjoyed a normal day of comfort, good health, or solid sleep due to coughing, expelling excretions and experiencing feelings of general fatigue and ill health. The patient recovered from the events, ecchymosis, rash macular, burning sensation, chronic cough, swelling arm, bronchitis, vaccination site erythema, vaccination site swelling. The patient did not recover from the events, congestion nasal, shortness of breath; while clinical outcome of the other events was unknown. Follow-up (11Apr2016): New information reported from the contactable consumer includes: patient details (gender provided), reaction data and case seriousness changed from non-serious to serious (hospitalization).
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 75-year-old female patient received, on 15Jul2015, PREVNAR 13 single dose, in arm. Relevant medical history and concomitant medications were unknown. The patient yearly received Influenza vaccine, as well as unspecified pneumococcal vaccine and has never had an adverse reaction. The patient experienced the following adverse events: injection site swelling, black mark, red circle, burning (slight), all on an unknown date in Jul2015 (within hours from vaccination); chronic cough from 15Jul2015 until Dec2015 (treated with benzonatate 100 mg); severe bronchitis from 20Jul2015 to 30Sep2015 (treated with doxycycline 100 mg); trouble sleeping due to coughing; congestion, and shortness of breath from 22Jul2015; red injection site, immune system disorder, fatigue, malaise (she was not feeling well) and expelling excretions from an unspecified date. The consumer reported that at the injection site the arm swelled to three times normal site: a black mark dotted the flesh where the needle was injected: the site was encircled, bright red and burning to the touch. The doctor was notified and took measurements for swelling and redness and administered an antibiotic and a prescription for a 10 day regimen of cephalexin 500 mg. As of 09Dec2015 the consumer was still coughing hacking and expelling from nose and throat. The consumer underwent lung X-rays on 03Sep2015 and chest X-rays on 12Nov2015, both showing no problem with heart or lungs. The consumer felt the entire immune system was compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the consumer had not enjoyed a normal day of comfort, good health, or solid sleep due to coughing, expelling excretions and experiencing feelings of general fatigue and ill health. The patient recovered from the events, ecchymosis, rash macular, burning sensation, chronic cough, swelling arm, bronchitis, vaccination site erythema, vaccination site swelling. The patient did not recover from the events, congestion nasal, shortness of breath; while clinical outcome of the other events was unknown. Follow-up (11Apr2016): New information reported from the contactable consumer includes: patient details (gender provided), reaction data and case seriousness changed from non-serious to serious (hospitalization).
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash macular, Respiratory tract congestion, Rhinorrhoea, X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 75-year-old female patient received, on 15Jul2015, PREVNAR 13 single dose, in arm. Relevant medical history and concomitant medications were unknown. The patient yearly received Influenza vaccine, as well as unspecified pneumococcal vaccine and has never had an adverse reaction. The patient experienced the following adverse events: injection site swelling, black mark, red circle, burning (slight), all on an unknown date in Jul2015 (within hours from vaccination); chronic cough from 15Jul2015 until Dec2015 (treated with benzonatate 100 mg); severe bronchitis from 20Jul2015 to 30Sep2015 (treated with doxycycline 100 mg); trouble sleeping due to coughing; congestion, and shortness of breath from 22Jul2015; red injection site, immune system disorder, fatigue, malaise (she was not feeling well) and expelling excretions from an unspecified date. The consumer reported that at the injection site the arm swelled to three times normal site: a black mark dotted the flesh where the needle was injected: the site was encircled, bright red and burning to the touch. The doctor was notified and took measurements for swelling and redness and administered an antibiotic and a prescription for a 10 day regimen of cephalexin 500 mg. As of 09Dec2015 the consumer was still coughing hacking and expelling from nose and throat. The consumer underwent lung X-rays on 03Sep2015 and chest X-rays on 12Nov2015, both showing no problem with heart or lungs. The consumer felt the entire immune system was compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the compromised once the pneumococcal vaccine was given. It has been five months since the shot was administered that the consumer had not enjoyed a normal day of comfort, good health, or solid sleep due to coughing, expelling excretions and experiencing feelings of general fatigue and ill health. The patient recovered from the events, ecchymosis, rash macular, burning sensation, chronic cough, swelling arm, bronchitis, vaccination site erythema, vaccination site swelling. The patient did not recover from the events, congestion nasal, shortness of breath; while clinical outcome of the other events was unknown. Follow-up (11Apr2016): New information reported from the contactable consumer includes: patient details (gender provided), reaction data and case seriousness changed from non-serious to serious (hospitalization).
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Fever, swelling of arm in area of injection, pain, itchiness. Blew up to the size of a baseball flattened out. Redness as well. KEFLEX and steroids
Sex: M
Vaccine: VARZOS
Symptoms: Eye operation, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a field employee refers to a male patient of an unknown age. The patient had a previous case of zoster shingles. The patient's concurrent condition and concomitant medication were not reported. On an unspecified date in December-2015, the patient was vaccinated with ZOSTAVAX lot number: L028283 (expiry date: 28-OCT-2016). On an unspecified date, within 4 days of ZOSTAVAX the patient experienced a significant case of ophthalmic zoster. On an unspecified date, the patient sought medical attention with his primary care physician and currently (at the time of report) was under his care. The patient had an "eye surgery on an unspecified date due to the ophthalmic zoster". It was reported that the patient could possibly be placed on an unspecified long term antiviral therapy. The outcome of the event was reported as not recovered (at the time of report). The reporter did not provide any causality assessment between event and ZOSTAVAX. No further information provided. Upon internal review, ophthalmic zoster (eye surgery due to the ophthalmic zoster) determined to be medically significant (query pending). Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Aggression, Aphasia, Autism, Seizure
Clinical narrative: This spontaneous report was received from a mother of patient who is a registered nurse, and refers to a currently 12-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date between 2003-2008 (reported as when the patient was a young child), he was vaccinated with the first dose of M-M-R II (dose, route of administration and lot # were not reported). 8 hours after vaccination, the patient experienced seizure, was taken by ambulance to a hospital and his outcome was reported as quit progressing after that. On an unknown date, the patient was vaccinated with the second dose of M-M-R II (dose, route of administration and lot # were not reported). On unknown date after that he became violent, did not speak, and was diagnosed with autism. After many years of different therapies the patient was "doing incredibly well" according to the reporter. The relatedness between the events and the vaccine was not provided. Upon internal review, the event of seizure was considered to be medically significant adverse event. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from healthcare professional (registered pharmacist) on 29 April 2015. This case is linked to the case 2015SA057712 (same reporter, different patient) A female patient, whose age, medical history and concomitant medication were not reported, had received first dose of ADACEL (batch number: U5213BA, expiration date and dose not reported) intramuscularly in left deltoid on 27 April 2015. It was reported that patient had not received any previous dose of ADACEL. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown and the patient had no illness at the time of vaccination. On 27 April 2015, same day after vaccination, patient had experienced redness at injection site and also injection site was hurting. On 28 April 2015, one day after vaccination, the patient's blood pressure was increased. Other laboratory investigation and corrective treatment were not reported. At the time of this report, patient had not recovered from the event of redness at injection site/injection site hurting and the event of BP increased was recovering. List of documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse on 30-Mar-2016. This case involves a 48-year-old male patient, who was vaccinated with a dose of ADACEL (batch number: U5235AA, expiry date not reported) via intramuscular route in left arm on 11-Mar-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other vaccinations within 4 weeks and concomitant medications were not reported. On 12-Mar-2016, next day after vaccination, the patient experienced fever, nausea, bodyaches, joint pain, headache, stiffness and fatigue. The patient also experienced swollen lymph nodes under left arm, the area from shoulder to elbow of left arm was warm to touch, red and swollen and also experienced tingling of arm. The symptoms continued or worsened over next 4 days. It was reported that patient required doctor visit on 15-Mar-2016 for treatment. The patient was also referred to allergist for evaluation for possible allergic reaction. Laboratory investigations was not reported. Patient's corrective treatment included one tablet of sulfamethoxazole trimethoprim 800/160 mg every 12 hours for 10 days. The outcome of the events was reported as unknown. Documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Lymphadenopathy, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Initial unsolicited report received from a nurse on 30-Mar-2016. This case involves a 48-year-old male patient, who was vaccinated with a dose of ADACEL (batch number: U5235AA, expiry date not reported) via intramuscular route in left arm on 11-Mar-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other vaccinations within 4 weeks and concomitant medications were not reported. On 12-Mar-2016, next day after vaccination, the patient experienced fever, nausea, bodyaches, joint pain, headache, stiffness and fatigue. The patient also experienced swollen lymph nodes under left arm, the area from shoulder to elbow of left arm was warm to touch, red and swollen and also experienced tingling of arm. The symptoms continued or worsened over next 4 days. It was reported that patient required doctor visit on 15-Mar-2016 for treatment. The patient was also referred to allergist for evaluation for possible allergic reaction. Laboratory investigations was not reported. Patient's corrective treatment included one tablet of sulfamethoxazole trimethoprim 800/160 mg every 12 hours for 10 days. The outcome of the events was reported as unknown. Documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 30-Mar-2016. This case involves a 48-year-old male patient, who was vaccinated with a dose of ADACEL (batch number: U5235AA, expiry date not reported) via intramuscular route in left arm on 11-Mar-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other vaccinations within 4 weeks and concomitant medications were not reported. On 12-Mar-2016, next day after vaccination, the patient experienced fever, nausea, bodyaches, joint pain, headache, stiffness and fatigue. The patient also experienced swollen lymph nodes under left arm, the area from shoulder to elbow of left arm was warm to touch, red and swollen and also experienced tingling of arm. The symptoms continued or worsened over next 4 days. It was reported that patient required doctor visit on 15-Mar-2016 for treatment. The patient was also referred to allergist for evaluation for possible allergic reaction. Laboratory investigations was not reported. Patient's corrective treatment included one tablet of sulfamethoxazole trimethoprim 800/160 mg every 12 hours for 10 days. The outcome of the events was reported as unknown. Documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 8 April 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of (TD) (dose, dose in series, batch number, route and site of administration was not reported) on an unspecified date 10 years ago. Patient's medical history and concomitant medications were not reported. On an unspecified date (10 years ago), following the vaccination, the patient's arm swelled almost twice the size and was red. She could not lift her arm the next day. Patient required emergency room/physician visit. Patient's lab data and corrective treatment were not reported. Few days after onset, the patient was recovered from the events. List of documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 22-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to "about 3" patients of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L035126 and expiration date: 14-SEP-2017; data logger; dose and route not reported). There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant referring to a 14 year old male patient with no drug allergies or pertinent medical history. On 05-APR-2016 the patient was vaccinated with a dose of 0.5 ml GARDASIL 9 (lot # L037339 and expiration date: 09-FEB-2018) intramuscular in the right arm. There was no concomitant therapy. On 06-APR-2016, the patient developed cellulitis of right arm. The patient sought unspecified medical attention and was treated with KEFLEX. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering from cellulitis. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 08-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in March 2016 (reported as "some time in March 2016"), the patient was vaccinated with a first dose in series of PROQUAD (dose, route of administration, lot# and expiration date were not reported) concomitantly with a first dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported) (which was verified by the reporter). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 26-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 18-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L0321834, expiration date 25-NOV-2016, dose and route unknown). The vaccines were stored under 3 degree centigrade for 13 hours and 8 minutes. There was previous temperature excursion. It was called because of a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 2 or 3 patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (dose and route not reported; lot # K005323 and expiration date: 10-FEB-2017; data logger). There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Between 19-MAR-2016 and 10-APR-2016, these patients were vaccinated with improperly stored doses in VARIVAX (Merck) (lot # reported as L043622, expiration date 03-NOV-2017, dose and route were not reported. Previous temperature excursion was reported as first excursion: -4.4C for 40 hours and second excursion: -3.8C for 17 hours. The vaccine was also stored in 0.9C for 20 hours. Digital data logger was used. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the partial doses of ZOSTAVAX (0.65 ml route of administration, lot # and expiration date were not reported). It was provided that the nurses at the practice were drawing up the full volume of the diluent to reconstitute ZOSTAVAX and only administering 0.65 ml of the total volume and wasting the rest of the reconstituted vaccine. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored VAIRVAX (Merck) (lot # L010145, expiry date 24-MAR-2017, dose and route were unspecified). The reporter stated that the VARIVAX (Merck) was exposed to the following conditions: Temperature: 12F for 90 minutes; previous temperature excursion: 24F for 8 hours. This report was because of a "data logger". No adverse symptom was reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 19-APR-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K007825, expiration date 13-JAN-2016). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough
Clinical narrative: Based on additional information received on 25 August 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional (consumer) 11 August 2015. A female patient (age not reported), whose concomitant medications were not reported, had received an intramuscular first dose of ADACEL (batch number, expiry date site of administration not reported) on an unspecified date 2 weeks ago. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies (NKA) and illness at time of vaccination was coughing two weeks ago and the patient had a negative test for whooping cough. On an unspecified date, 1 week after the vaccination the patient still continued to cough/whooping cough. The patient required ER visit. The patient had another blood test which was found to be positive for whooping cough. Corrective treatments and laboratory investigations were not reported. Upon medical review, the case was considered as serious due to important medical event: whooping cough. At the time of this report, the event outcome was not recovered. Follow-up information received from a physician on 25 August 2015. A 61-year-old female patient had received a dose of Adacel vaccine on an unknown date. On 22 June 2015, laboratory investigations included pertussis toxin (PT) IgG: 11 IU/ml, PT IgA: less than 1 IU/ml, filamentous hemagglutinin antigen (FHA). Previous results included PT IgG: less than 1 IU/ml, PT IgA: less than 1 IU/ml, FHA IgG: 6 IU/ml and FHA IgA: less than 1 IU/ml. and on 03 aug 2015 reported IgG: 130 IU/ml (high) and FHA IgA: 65 IU/ml (high). It was reported that levels of antibodies recognizing pertussis toxin (PT) and filamentous hemagglutinin (FHA) were increased following the vaccination or natural exposure to Bordetella pertussis. This assay was not appropriate to assess the immunity to pertussis as the specific antibodies and antibody levels that correlate with protection were not well defined. Follow up information received from a physician on 18 September 2015. There was no additional information provided. Corrected report of the previous follow-up; It was reported that the patient had tracheobronchitis on an unspecified date which was manifested by a persistent cough. The patient was treated for tracheobronchitis. List of documents held by sender: none. Sender's Comments: Follow up received on 25 Jan 2015, dose not changes the assessment. As with any other vaccine, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE vaccination may not protect 100% of susceptible individuals. Aspects such as patient's immune status at the time of vaccination might interfere with the immune response to the vaccine. Blood test showed positive hence PERTUSSIS was confirmed. However patient's immune status, medical history, concomitant medication etc. is require to further assess this case.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Haematochezia, Irritability, Ultrasound scan normal, X-ray normal
Clinical narrative: Pt presented to Hospital ED for possible blood in stool. Per parents reported currant jelly stool, parents have photo documentation on their phone. Pt discharged from the ED. Seen at Clinic 04/18/2018 by Dr. for r/o intussusception d/t Rotavirus vaccine. Vaccine was GlaxoSmithKline ROTARIX, lot number A41CB554A. Per parents pt never stooled again after initial blood stool. Pt had been irritable but consolable. Parents denied sausage "lump" on stomach wall, emesis, and fever.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site haematoma, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Knot on left thigh at injection site, warm, tender. Per MD appears to be small, calcified hematoma, no signs of infection.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itching, redness, swelling, and mild warmth.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report was received from a consumer via her husband and was published in a newspaper article. Obtained information refers to a 18 year old male patient (reporter's son). No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with M-M-R II injection (dose, route of administration, lot # and expiration date were not reported). The reporter stated that her son changed overnight after having a jab and became autistic (dates unspecified). The outcome of the adverse event was not reported. The reporter claimed a connection between the adverse event and M-M-R II. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9, lot # K016966, Expiration Date 10-MAY-2017, strength, dose and route not provided). The GARDASIL was exposed to 32F for 15 days (360 hours). There was no previous temperature excursion. It was called because of a "data logger". No adverse symptoms reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 56-year-old female patient received PREVNAR 13 at 0.5ml single dose via intramuscular route on 04Apr2016. On 07Apr2016 the patient experienced cellulitis with outcome of not recovered. Consumer stated that she still had cellulitis and it was worsened. The patient received treatment for the event which included cephalosporin antibiotics.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Lethargy, Pruritus, Rash, Rash erythematous
Clinical narrative: SPOTS APPEARED ON CHILD'S TRUNK, SCALING LOOKING SKIN, DENIES FEVER; RED NON RAISED NON WEEPING SPOTS SPREAD FOR 3 DAYS AND WERE ALSO FOUND ON LEGS AND HEAD REGIONS. CHILD COMPLAINED OF INTENSE ITCHING AND IS ACTING LETHARGIC; COOL BATH FAILED TO ALLEVIATE DISCOMFORT; MOTHER REPORTED THAT SHE WOULD BE TAKING CHILD TO DOCTOR OFFICE.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Skin exfoliation
Clinical narrative: SPOTS APPEARED ON CHILD'S TRUNK, SCALING LOOKING SKIN, DENIES FEVER; RED NON RAISED NON WEEPING SPOTS SPREAD FOR 3 DAYS AND WERE ALSO FOUND ON LEGS AND HEAD REGIONS. CHILD COMPLAINED OF INTENSE ITCHING AND IS ACTING LETHARGIC; COOL BATH FAILED TO ALLEVIATE DISCOMFORT; MOTHER REPORTED THAT SHE WOULD BE TAKING CHILD TO DOCTOR OFFICE.
Age: 1.13
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site red and swollen.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Abdominal pain upper, Abnormal faeces, Blood test, Chills
Clinical narrative: This is a spontaneous report from a contactable consumer. A 55-year-old female patient started to receive PREVNAR 13 on 11Jan2016 at 09:30 at single dose in right arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. She had influenza vaccine in Oct2015, with no adverse event. After receiving the PREVNAR 13 vaccine, within an hour, she had what sounds like an allergic reaction. On 11Jan2016 (within one hour from vaccination) patient experienced swelling of throat and dizziness; on 11Jan2016 (within 6 hours from vaccination) she had fever, chills, shakes/ still shake intermittently; on 11Jan2016 (within 10 hours from vaccination) had dry cough; on 11Jan2016 (within 24 hours from vaccination) she had swelling of face, due to which was hospitalized; on11Jan2016 she had a hard time having a bowel movement after receiving the vaccine, which was unusual for her. She wanted to go but could not, she felt clogged up. On 12Jan2016 she had cramping of stomach, sick of stomach, discoloration urine and unbelievably stinky bowel movement with very different smell; she still feel different/did not feel normal as of 13Mar2016 and she was extremely tired from an unknown date. Patient had had two chest colds between 11Jan2016-01Apr2016. She stated she normally had chest cold every two-three years, and now she had 2 in 3 months which lasts weeks. She called her doctor when she started experiencing the side effects and she was told to take BENADRYL for swelling of throat, so she took it from 11Jan2016 to 14Jan2016. She had blood drawn on 11Jan2016, but has not received the results yet. She reported she will not be getting the pneumococcal 23 vaccine. Swelling of throat recovered on 11Feb2016; swelling of face and fever recovered on 15Jan2016; chills recovered on 14Jan2016; shakes/ still shake intermittently and feel different not recovered; dizziness recovered on 30Jan2016; cramping of stomach and sick of stomach recovered on 12Feb2016; dry cough recovered on 30Jan2016, then returned on 01Apr2016 and not recovered; discoloration urine recovered on 12Jan2016; difficulty having a bowel movement was recovering; unbelievably stinky bowel movement and extremely tired had unknown outcome; chest colds recovered in 2016. Follow-up (01Apr2016): New information received from a contactable consumer includes: event details/course, new events, seriousness.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Chromaturia, Constipation, Cough, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer. A 55-year-old female patient started to receive PREVNAR 13 on 11Jan2016 at 09:30 at single dose in right arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. She had influenza vaccine in Oct2015, with no adverse event. After receiving the PREVNAR 13 vaccine, within an hour, she had what sounds like an allergic reaction. On 11Jan2016 (within one hour from vaccination) patient experienced swelling of throat and dizziness; on 11Jan2016 (within 6 hours from vaccination) she had fever, chills, shakes/ still shake intermittently; on 11Jan2016 (within 10 hours from vaccination) had dry cough; on 11Jan2016 (within 24 hours from vaccination) she had swelling of face, due to which was hospitalized; on11Jan2016 she had a hard time having a bowel movement after receiving the vaccine, which was unusual for her. She wanted to go but could not, she felt clogged up. On 12Jan2016 she had cramping of stomach, sick of stomach, discoloration urine and unbelievably stinky bowel movement with very different smell; she still feel different/did not feel normal as of 13Mar2016 and she was extremely tired from an unknown date. Patient had had two chest colds between 11Jan2016-01Apr2016. She stated she normally had chest cold every two-three years, and now she had 2 in 3 months which lasts weeks. She called her doctor when she started experiencing the side effects and she was told to take BENADRYL for swelling of throat, so she took it from 11Jan2016 to 14Jan2016. She had blood drawn on 11Jan2016, but has not received the results yet. She reported she will not be getting the pneumococcal 23 vaccine. Swelling of throat recovered on 11Feb2016; swelling of face and fever recovered on 15Jan2016; chills recovered on 14Jan2016; shakes/ still shake intermittently and feel different not recovered; dizziness recovered on 30Jan2016; cramping of stomach and sick of stomach recovered on 12Feb2016; dry cough recovered on 30Jan2016, then returned on 01Apr2016 and not recovered; discoloration urine recovered on 12Jan2016; difficulty having a bowel movement was recovering; unbelievably stinky bowel movement and extremely tired had unknown outcome; chest colds recovered in 2016. Follow-up (01Apr2016): New information received from a contactable consumer includes: event details/course, new events, seriousness.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Hypersensitivity, Lower respiratory tract infection, Nausea, Pharyngeal oedema
Clinical narrative: This is a spontaneous report from a contactable consumer. A 55-year-old female patient started to receive PREVNAR 13 on 11Jan2016 at 09:30 at single dose in right arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. She had influenza vaccine in Oct2015, with no adverse event. After receiving the PREVNAR 13 vaccine, within an hour, she had what sounds like an allergic reaction. On 11Jan2016 (within one hour from vaccination) patient experienced swelling of throat and dizziness; on 11Jan2016 (within 6 hours from vaccination) she had fever, chills, shakes/ still shake intermittently; on 11Jan2016 (within 10 hours from vaccination) had dry cough; on 11Jan2016 (within 24 hours from vaccination) she had swelling of face, due to which was hospitalized; on11Jan2016 she had a hard time having a bowel movement after receiving the vaccine, which was unusual for her. She wanted to go but could not, she felt clogged up. On 12Jan2016 she had cramping of stomach, sick of stomach, discoloration urine and unbelievably stinky bowel movement with very different smell; she still feel different/did not feel normal as of 13Mar2016 and she was extremely tired from an unknown date. Patient had had two chest colds between 11Jan2016-01Apr2016. She stated she normally had chest cold every two-three years, and now she had 2 in 3 months which lasts weeks. She called her doctor when she started experiencing the side effects and she was told to take BENADRYL for swelling of throat, so she took it from 11Jan2016 to 14Jan2016. She had blood drawn on 11Jan2016, but has not received the results yet. She reported she will not be getting the pneumococcal 23 vaccine. Swelling of throat recovered on 11Feb2016; swelling of face and fever recovered on 15Jan2016; chills recovered on 14Jan2016; shakes/ still shake intermittently and feel different not recovered; dizziness recovered on 30Jan2016; cramping of stomach and sick of stomach recovered on 12Feb2016; dry cough recovered on 30Jan2016, then returned on 01Apr2016 and not recovered; discoloration urine recovered on 12Jan2016; difficulty having a bowel movement was recovering; unbelievably stinky bowel movement and extremely tired had unknown outcome; chest colds recovered in 2016. Follow-up (01Apr2016): New information received from a contactable consumer includes: event details/course, new events, seriousness.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Swelling face, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 55-year-old female patient started to receive PREVNAR 13 on 11Jan2016 at 09:30 at single dose in right arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. She had influenza vaccine in Oct2015, with no adverse event. After receiving the PREVNAR 13 vaccine, within an hour, she had what sounds like an allergic reaction. On 11Jan2016 (within one hour from vaccination) patient experienced swelling of throat and dizziness; on 11Jan2016 (within 6 hours from vaccination) she had fever, chills, shakes/ still shake intermittently; on 11Jan2016 (within 10 hours from vaccination) had dry cough; on 11Jan2016 (within 24 hours from vaccination) she had swelling of face, due to which was hospitalized; on11Jan2016 she had a hard time having a bowel movement after receiving the vaccine, which was unusual for her. She wanted to go but could not, she felt clogged up. On 12Jan2016 she had cramping of stomach, sick of stomach, discoloration urine and unbelievably stinky bowel movement with very different smell; she still feel different/did not feel normal as of 13Mar2016 and she was extremely tired from an unknown date. Patient had had two chest colds between 11Jan2016-01Apr2016. She stated she normally had chest cold every two-three years, and now she had 2 in 3 months which lasts weeks. She called her doctor when she started experiencing the side effects and she was told to take BENADRYL for swelling of throat, so she took it from 11Jan2016 to 14Jan2016. She had blood drawn on 11Jan2016, but has not received the results yet. She reported she will not be getting the pneumococcal 23 vaccine. Swelling of throat recovered on 11Feb2016; swelling of face and fever recovered on 15Jan2016; chills recovered on 14Jan2016; shakes/ still shake intermittently and feel different not recovered; dizziness recovered on 30Jan2016; cramping of stomach and sick of stomach recovered on 12Feb2016; dry cough recovered on 30Jan2016, then returned on 01Apr2016 and not recovered; discoloration urine recovered on 12Jan2016; difficulty having a bowel movement was recovering; unbelievably stinky bowel movement and extremely tired had unknown outcome; chest colds recovered in 2016. Follow-up (01Apr2016): New information received from a contactable consumer includes: event details/course, new events, seriousness.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. An adult patient of an unspecified ethnicity and gender received a single dose of PREVNAR 13, on an unspecified date Mar2016. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2016 the patient experienced very red, swollen area on arm so went to an immediate care clinic. Patient was diagnosed with cellulitis and prescribed antibiotics. The outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5ml, single at a pharmacy. The patient medical history and the patient's concomitant medications were not reported. The patient experienced did not feel well and felt achy on an unspecified date with outcome of unknown. The events were assessed as serious per hospitalization.