chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This solicited report as received from a consumer via a vendor refers to a 67-year-old female patient enrolled in a market research. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of eumonia/pneumococcal (disease) vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient experienced a very bad reacting to the vaccine. The outcome of the adverse event was not reported. The adverse event was considered to be related to pneumonia/pneumococcal (disease) vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with a improperly stored M-M-R II, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The vaccines were exposed to temperatures between 46 Fahrenheit and 77 Fahrenheit during 1 hour. There was no previous temperature excursion reported and data logger was filed. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA009049.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (reported lot # as: M023169 with expiration date: 13-JUN-2018 and L037554 with expiration date: 25-DEC-2017 and L037554 with expiration date: 25-DEC-2017). However, dosage number and route of administration were not reported, for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 60 hours between 32 grades Fahrenheit and 36 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ orally, with lot # L020859 and expiration date on 19-JAN-2017 and with lot # L023870 with expiration date on 20-APR-2017 for prophylaxis. It was stated that, ROTATEQ, was exposed to a temperature of > 8°C but < 25°C, for a 677 hours time frame. Data logger was involved. Furthermore, ROTATEQ was never exposed to previous temperature excursions and a product quality issue was not reported. No adverse effects were suffered. This is one of several reports received from the same reporter. Additional information is not expected as consent to follow up was not provided. Sender's Comments: US-009507513-1702USA009046: US-009507513-1702USA009047: US-009507513-1702USA009048.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M009378 for prophylaxis, expiration date: 23-APR-2018 for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009041: US-009507513-1702USA009043: US-009507513-1702USA009044: US-009507513-1702USA009040: US-009507513-1702USA009042.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an office manager refers to a non-pregnant female patient who is currently 81 years old. While she had no drug reactions/ allergies, her medical history, concurrent conditions and concomitant medications were not reported. On 15-NOV-213, the patient was vaccinated with ZOSTAVAX (which had a lot # of H019092 with an expiration date of 09-FEB-2014; however, the dose, dosage number, and anatomical location were unknown), intramuscularly, for prophylaxis. Subsequently, on an unknown date, the patient developed shingles. She sought medical attention by going to the doctor's office, where she received an unknown treatment. The outcome of the event, and the causal relationship between the event and the vaccine were unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ Lot# M031802, expiration date: 09-NOV-2017, orally for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA009042: US-009507513-1702USA009043: US-009507513-1702USA006132: US-009507513-1702USA009041.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 Lot# reported 1013428, expiration date: 03-FEB-2017 for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA009042: US-009507513-1702USA009043: US-009507513-1702USA009040: US-009507513-1702USA006132.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA, Lot# M018644, expiration date: 20-SEP-2017 for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA006132: US-009507513-1702USA009043: US-009507513-1702USA009040: US-009507513-1702USA009041.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB Lot# M032148, expiration date: 18-APR-2019 for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009044: US-009507513-1702USA009042: US-009507513-1702USA006132: US-009507513-1702USA009040: US-009507513-1702USA009041:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006132: US-009507513-1702USA009042: US-009507513-1702USA009043: US-009507513-1702USA009040: US-009507513-1702USA009041.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of vaccinated with RECOMBIVAX HB with lot # L025738 and expiration date on 14-AUG-2017 and with lot # L048848 with expiration date on 09-AUG-2018 for prophylaxis. It was stated that, RECOMBIVAX HB with lot # L025738, was exposed to a temperature of > 8°C but < 25°C, for a 677 hours time frame and RECOMBIVAX HB with lot # L048848 was exposed to a temperature excursion of > 8°C but < 25°C for 568 hours and 30 minutes time frame. Data logger was involved. Furthermore, RECOMBIVAX HB was never exposed to previous temperature excursions and a product quality issue was not reported. No adverse effects were suffered. This is one of several reports received from the same reporter. Additional information is not expected as consent to follow up was not provided.; Sender's Comments: US-009507513-1702USA006117: US-009507513-1702USA009047: US-009507513-1702USA009048:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-R II with lot # L039551 and expiration date on 07-OCT-2017 (anatomical route of vaccination was not provided) for prophylaxis. It was stated that, M-M-R II, was exposed to a temperature of > 8°C but < 25°C, for a 568 hours and 45 minutes time frame. Data logger was involved. Furthermore, M-M-R II was never exposed to previous temperature excursions and a product quality issue was not reported. No adverse effects were suffered. This is one of several reports received from the same reporter. Additional information is not expected as consent to follow up was not provided. Sender's Comments: US-009507513-1702USA006117: US-009507513-1702USA009046: US-009507513-1702USA009048.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 with lot # L043213 and expiration date on 28-AUG-2017 (anatomical route of vaccination was not provided) for prophylaxis. It was stated that, GARDASIL 9, was exposed to a temperature of > 8°C but < 25°C, for a 677 hours time frame. Data logger was involved. Furthermore, GARDASIL 9 was never exposed to previous temperature excursions and a product quality issue was not reported. No adverse effects were suffered. This is one of several reports received from the same reporter. Additional information is not expected as consent to follow up was not provided. Sender's Comments: US-009507513-1702USA006117: US-009507513-1702USA009046: US-009507513-1702USA009047.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with a improperly stored PNEUMOVAX23, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The vaccines were exposed to temperatures between 46 Fahrenheit and 77 Fahrenheit during 1 hour. There was no previous temperature excursion reported and data logger was filed. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002831:
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported similar events for 3 patients. This report is for 2nd of 3 patients. An elderly female patient of an unspecified ethnicity received PREVNAR 13 (Lot# R33240, expiring date Mar2018, NDC # 0005197101) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 1-2 days post injection, the patient experienced redness at injection site/large area of redness at site, itching to the site, heat to the site, swelling. The outcome was unknown. Staff found this very unusual and concerning and pulled the lot from their stock. The nurse considered there was a reasonable possibility that the events were related to the suspect product. There was a product complaint to report filed. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017063635 same reporter/drug/event, different patient; US-PFIZER INC-2017063627 same reporter/drug, similar events/patient.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable reporter (a manager). This is the 2nd case out of the 2 cases. A 66-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot# R12276, Exp date Feb2018, NDC 0051971-02) via an unspecified route of administration at 0.5ml, single at right deltoid on 07Feb2017 for immunisation. The patient medical history and concomitant medications were not reported. The next morning, on 08Feb2017, the patient experienced redness and intensive swelling with outcome of unknown. The patient actually ended up going to the emergency room for the reaction to the shot.
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a sales representative. A 65-year-old male patient received PREVNAR 13 on an unspecified date at 0.5 ml single for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date after vaccination with unknown outcome. The reporting pharmacist considered the event was related to vaccination.
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling, Musculoskeletal stiffness, Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient received PREVNAR 13 on an unspecified date in Jan2017, in upper arm, at 0.5 ml single, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2017 the patient experienced really bad rash, stiffness and skin was like hard and swollen in the upper arm where she received the injection. Events outcome was unknown.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Headache, Initial insomnia, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016518549) on 03-Feb-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of 0.5 ml of INFLUENZA VACCINE (Flu Shot) intramuscularly (batch number:UI62622, expiry date and dose in series were not reported) in the right deltoid muscle on 21-Oct-2016. It was also reported that the patient had received PREVNAR 13 intramuscularly into left deltoid muscle on 30-Aug-2016. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had developed fatigue, mild headache, pain and sometimes trouble in falling asleep (awaken every day between 3-5 am). Laboratory investigations included as X-ray and Magnetic resonance imaging (MRIS) was performed on an unknown date. The patient received corrective treatment as Ibuprofen and physical therapy. On an unknown day, the outcome of the event as mild headache was recovered (reported as headache is mostly better). The outcome of other events as fatigue, pain and difficulty sleeping was not reported. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016518549) on 03-Feb-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of 0.5 ml of INFLUENZA VACCINE (Flu Shot) intramuscularly (batch number:UI62622, expiry date and dose in series were not reported) in the right deltoid muscle on 21-Oct-2016. It was also reported that the patient had received PREVNAR 13 intramuscularly into left deltoid muscle on 30-Aug-2016. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had developed fatigue, mild headache, pain and sometimes trouble in falling asleep (awaken every day between 3-5 am). Laboratory investigations included as X-ray and Magnetic resonance imaging (MRIS) was performed on an unknown date. The patient received corrective treatment as Ibuprofen and physical therapy. On an unknown day, the outcome of the event as mild headache was recovered (reported as headache is mostly better). The outcome of other events as fatigue, pain and difficulty sleeping was not reported. List of documents held by sender: none.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Autonomic nervous system imbalance, Migraine, Pain, Postural orthostatic tachycardia syndrome, Pyrexia
Clinical narrative: Fever, aches, blurred vision, autonomic dysfunction (POTS), migraines and more.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Fever, aches, blurred vision, autonomic dysfunction (POTS), migraines and more.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Pharyngeal oedema, Wheezing
Clinical narrative: Shortness of Breath, mild wheezing, felt throat was swelling and breathing was difficult. No hives.  Patient assessed by nurse in emergency room but left without being seen after father, who is a physician came to emergency room to assess.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Condition aggravated, Fatigue, Food allergy, Headache
Clinical narrative: Fever, which lasted 6 weeks after the immunization. Enlarged lymph nodes in my armpit and throat. Extreme fatigue and weakness...sleeping 12-15 hours per day, which lasted for months after the vaccination. 7 months out, I am still disabled by fatigue and pain. Muscle aches and weakness.  Flu-like, and still happening after 7 months.  I was swimming, hiking and dancing prior to the vaccine. Significant exacerbation of pre-existing food and environmental allergies. Significant increase in systemic symptoms of inflammation. Dramatic increase in headaches and migraines.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Hypersomnia, Inflammation, Influenza like illness, Lymphadenopathy
Clinical narrative: Fever, which lasted 6 weeks after the immunization. Enlarged lymph nodes in my armpit and throat. Extreme fatigue and weakness...sleeping 12-15 hours per day, which lasted for months after the vaccination. 7 months out, I am still disabled by fatigue and pain. Muscle aches and weakness.  Flu-like, and still happening after 7 months.  I was swimming, hiking and dancing prior to the vaccine. Significant exacerbation of pre-existing food and environmental allergies. Significant increase in systemic symptoms of inflammation. Dramatic increase in headaches and migraines.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, which lasted 6 weeks after the immunization. Enlarged lymph nodes in my armpit and throat. Extreme fatigue and weakness...sleeping 12-15 hours per day, which lasted for months after the vaccination. 7 months out, I am still disabled by fatigue and pain. Muscle aches and weakness.  Flu-like, and still happening after 7 months.  I was swimming, hiking and dancing prior to the vaccine. Significant exacerbation of pre-existing food and environmental allergies. Significant increase in systemic symptoms of inflammation. Dramatic increase in headaches and migraines.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Left shoulder pain after receiving flu shot on 10/05/2016. Limited range of motion, unable to raise arm above shoulder level without pain.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Hypoaesthesia, Migraine, Nausea, Paraesthesia
Clinical narrative: Tingling and numbness along trigeminal nerve on right side of face and down right arm (vaccine given on right arm). lasted until 7pm, around 4 pm, frontal migraine behind eyes, pupils pulsating, nausea and dizziness. better with sleep, still having symptoms today.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Pupillary disorder
Clinical narrative: Tingling and numbness along trigeminal nerve on right side of face and down right arm (vaccine given on right arm). lasted until 7pm, around 4 pm, frontal migraine behind eyes, pupils pulsating, nausea and dizziness. better with sleep, still having symptoms today.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MEN
Symptoms: Asthenia, Pallor, Syncope
Clinical narrative: Pt walked to check out and got weak, pale and fainted.
Age: 28.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Circumoral oedema, Periorbital oedema, Pruritus generalised, Rash generalised
Clinical narrative: Patient reports generalized rash and pruritis, with periorbital edema and perioral edema. Took Benadryl over the weekend, did not reach out to office until 2/21/17.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain after receiving flu shot.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain after receiving flu shot.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Grip strength decreased, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: Severe muscle spasms 2 days after injection received in rt arm. Swelling redness and severe pain in rt hand and arm (unable to hold a pen to sign my name). Then 1 week later my left hand became swollen and red. Treated in Emergency Ro on 10/2/16, 10/4/16, 10/6/16 and 10/8/16 and in Dr office on 10/3/16. (No elevated temperature) had residual pain until 12/31.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count normal
Clinical narrative: Severe muscle spasms 2 days after injection received in rt arm. Swelling redness and severe pain in rt hand and arm (unable to hold a pen to sign my name). Then 1 week later my left hand became swollen and red. Treated in Emergency Ro on 10/2/16, 10/4/16, 10/6/16 and 10/8/16 and in Dr office on 10/3/16. (No elevated temperature) had residual pain until 12/31.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Very light rash at injection site.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Diarrhoea, Dizziness, Myalgia, Nausea
Clinical narrative: Nausea, vomiting, diarrhea, lightheaded on 2/20/17. Then on 2/21/17 employee complained of lower back pain, general muscle pain, esp. in legs.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, lightheaded on 2/20/17. Then on 2/21/17 employee complained of lower back pain, general muscle pain, esp. in legs.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Pyrexia
Clinical narrative: DVELOPED FEVER EVERY ATFERNOON AND EVENING UNTIL 2/18 & 2/19 WHEN HAD FEVER ALL DAY. HIGHEST FEVER RECORDED WAS 103.1 AXILLARY. FEVER LOWEST ON 2/20, BUT TOOK CHILD TO HEALTH CARE PROVIDER THAT DAY. NO TREATMENT PRESCRIBED. NO RASH NOTED BY MOTHER.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Abnormal redness, swelling and tenderness; lasted approximately 3 days.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Culture urine negative, Febrile convulsion, Generalised tonic-clonic seizure, Influenza virus test negative, Pyrexia
Clinical narrative: Temperature of 102 degrees with generalized tonic clonic seizure x 5 minutes 5 days after 15 mo. vaccines. Went to ER. Dx with febrile seizure. Developed diffuse rash after fever stopped - question of roseola?
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Urine analysis normal
Clinical narrative: Temperature of 102 degrees with generalized tonic clonic seizure x 5 minutes 5 days after 15 mo. vaccines. Went to ER. Dx with febrile seizure. Developed diffuse rash after fever stopped - question of roseola?
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a male patient of unknown age. The patient's medical history included unspecified lung issues in the past. It was unknown by the reporter if the patient had any drug reaction/allergy. The patient received the first dose of PNEUMOVAX23 on an unspecified date in approximately 1999. On an unspecified date in 2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported), however, he was supposed to receive a dose of PREVNAR 13. On an unspecified date in approximately 2016 (reported as following the administration of the vaccine) the patient experienced  an injection site reaction described as painful, swollen and red (Injection site pain, injection site erythema and injection site swelling). The physician reported that the injection site reaction did resolve on an unspecified date but then the patient got sick (Malaise), he also reported that he recovered from the "sickness" on an unspecified date. It was unknown if treatment was given to the patient or if lab diagnostics studies were performed. The patient did seek medical attention for the events. The outcome of injection site pain, malaise, injection site erythema and injection site swelling was reported as recovered. The reporter did not provide the causality between the events and PNEUMOVAX23. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 05-MAR-2004 the patient was vaccinated with a dose of VARIVAX for prophylaxis (route, lot # and expiration date were not reported). On 15-MAR-2007, the patient was vaccinated with another dose of VARIVAX for prophylaxis (route, lot # and expiration date were not reported). On 01-FEB-2017, the patient was diagnosed with herpes zoster. It was stated that the patient was prescribed with ALEVE as treatment for the adverse event. At the time of reporting, the outcome of herpes zoster was unknown. A product quality complaint was not involved. The causality assessment between the event and VARIVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009059: US-009507513-1702USA009057: US-009507513-1702USA009058.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.  Sender's Comments: US-009507513-1702USA009058: US-009507513-1702USA009059: US-009507513-1702USA008645.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008645: US-009507513-1702USA009059: US-009507513-1702USA009057.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot# and expiration date were unknown) orally for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009058: US-009507513-1702USA008645: US-009507513-1702USA009057.
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a non-contactable consumer (patient's wife). A male patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient had a stiff neck for about a week, along with a sore arm. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy, Muscular weakness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (Office Manager) on 09-Feb-2017. This case involves a 62-year-old female patient, who was vaccinated with ADACEL via intramuscular route (batch number: U5478BA, expiry date: 05-Nov-2018; dose and dose in series not reported) in left deltoid on 22-Sep-2016. Patient's Illness at time of vaccination was reported as none and allergies towards penicillin and Compazine was reported. Patient's concomitant medication was not reported and any other vaccinations within four weeks of vaccinations were reported as none. On 22-Sep-2016 since time of the vaccination, patient had experienced arm pain, injection site swelling, swollen glands. On an unknown date, about one month after the vaccination, patient experienced muscle weakness of arm, patient stated that it felt like "arm muscle where shot was given is gone". Patient required an emergency room or doctor visit. Lab test and corrective treatment was not reported. Patient had not recovered from the events. It was also reported that till 09-Feb-2017, arm pain, injection site swelling, swollen glands were going on. Documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via Pfizer under reference number 2016554271 on 09 February 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination the patient experienced allergy. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Received shot in left arm. Resulting in left arm pain/shoulder pain increasing in severity and continuing for months and still remains (toothache (like) severe down total arm to fingers hurts to raise arm or lift things or to lie on (L) side.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Immediate post-injection reaction, Influenza like illness, Mobility decreased, Neurological examination
Clinical narrative: Immediate pain down right arm, significant pain and loss of use of 3rd and 4th digits on right hand, flu like symptoms. Extremely loose bowel movements since injection. I have seen my GP several times and had a neurological exam.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Immediate pain down right arm, significant pain and loss of use of 3rd and 4th digits on right hand, flu like symptoms. Extremely loose bowel movements since injection. I have seen my GP several times and had a neurological exam.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Burning sensation, Fatigue, Local swelling, Pain, Pain in extremity
Clinical narrative: Severe localized pain and swelling that progressed to whole arm pain x 1 week - hot and burning - fever 102+, fatigue.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Skin warm
Clinical narrative: Severe localized pain and swelling that progressed to whole arm pain x 1 week - hot and burning - fever 102+, fatigue.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Pt was given Hep A, MENVEO, HPV 9, he felt dizzy after about 2 minutes of administration. Applied ice pack, and orange juice. BP monitored pt evaluated for additional 20 minutes.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash generalised
Clinical narrative: Rec'd vaccines on date specified; mother called LHU to report pt had a rash; LHU was notified 2-9-17; mother informed nurse that pt "had a rash all over, but pt has had same rash several times" mother instructed to notify child's MD for evaluation since this rash has occurred prior; mother said ok.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: (R) deltoid - 3 cm wide bump - Iced for 10 mins bump went down.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4, FLUX, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately after administration of flu vaccine and GARDASIL vaccine. Observed in office x 1 and pt recovered.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4, FLUX, HPV9
Symptoms: Immediate post-injection reaction, Syncope, Tonic clonic movements
Clinical narrative: Syncope immediately after administration of flu vaccine and GARDASIL vaccine. Observed in office x 1 and pt recovered.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 61.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Abdominal distension, Blood test normal, Feeling abnormal, Headache, Liver function test normal
Clinical narrative: Monday PM 2/6/17 ate dinner had bloating of abdomen more than would expect for amount of food. Also got stiff neck and headache (had slept on friend's couch 2/3/17 so thinks maybe those 2 symptoms from sleeping on couch). In addition to bloating of abdomen 2/6/17 he had headache through the night and felt achy and run down. He continued to have symptoms 2/7/17 Tuesday so went to ER that afternoon around 4-4:30 PM. ER did lots of tests including blood tests including liver test and other blood work. ER did neurological exam, they did BP and temp. All tests normal. They gave him some IVs. He went home about 8:30 PM that evening 2/7/17. He felt lots better - good appetite, slept well (mild headache then) 2/8/17 Wed am back to normal.
Age: 61.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Musculoskeletal stiffness, Neurological examination normal, Pain
Clinical narrative: Monday PM 2/6/17 ate dinner had bloating of abdomen more than would expect for amount of food. Also got stiff neck and headache (had slept on friend's couch 2/3/17 so thinks maybe those 2 symptoms from sleeping on couch). In addition to bloating of abdomen 2/6/17 he had headache through the night and felt achy and run down. He continued to have symptoms 2/7/17 Tuesday so went to ER that afternoon around 4-4:30 PM. ER did lots of tests including blood tests including liver test and other blood work. ER did neurological exam, they did BP and temp. All tests normal. They gave him some IVs. He went home about 8:30 PM that evening 2/7/17. He felt lots better - good appetite, slept well (mild headache then) 2/8/17 Wed am back to normal.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Limb mass, Pain in extremity
Clinical narrative: Pain and lump in right arm. ART and ASTYM treatments-ongoing to this date.
Age: 7.0
Sex: M
Vaccine: TD
Symptoms: Dysphagia, Headache, Lymphadenopathy
Clinical narrative: Headache starting approximately 24 hrs. after vaccine administered - moderate severity. Gone upon waking next morning. Swollen glands. Unable to swallow vitamins - started 48 hrs. after vaccine, alleviated after 72 hrs.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Flu shot given in left arm. After 6 1/2 weeks, continued soreness and limited range of motion in the left arm.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Flu shot given in left arm. After 6 1/2 weeks, continued soreness and limited range of motion in the left arm.
Age: 81.0
Sex: F
Vaccine: HEP, HEPA, MEN, TYP
Symptoms: Anxiety, Feeling cold, Pain in extremity, Tremor
Clinical narrative: Pt reported she had severe right arm pain which  began shortly after vaccination and continued for several days. She went to pharmacy at 4:30 PM to seek assistance. Pharmacist called and talked with another nurse.  He reported that she was anxious, complaining of arm pain and feeling cold and shaky but breathing appeared stable. Pharmacist  advised to tell patient to see PCP for symptoms or 911 if progresses to acute distress. Follow-up telephone was made but no return call from patient.  Pt returned for subsequent vaccines.  Reported arm pain improved after several days.  No other information obtained.  Pt is now travelling out of the country.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Pruritus generalised, Skin lesion
Clinical narrative: Per inpatient note-developed lesions on his elbows that spread up and down the bilateral arms, on his mouth, and lastly on his legs. Notes the lesions are pruritic in nature.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cough, Dysphagia
Clinical narrative: PATIENT REPORTED TROUBLE SWALLOWING, MILD COUGH. BENADRYL 25MG PO GIVEN. PATIENT WAS ON OBSERVATION FOR 1 HOUR, REPORTED THE SYMPTOMS DISSAPEARED, NOT TROUBLE SWALLOWING, NO COUGH. VITAL SIGNS STABLE. PATIENT WAS PICKED UP BY A FAMILY MEMBER. FURTHER INSTRUCTIONS GIVEN TO VISIT HER PCP AND REPORT THE EVENT. ADVISED TO CALL 911 IF ANY COMPLICATIONS NOTED, PATIENT VERBALIZED UNDERSTANDING.
Age: 54.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Abasia, Abdominal pain, Asthenia, Dysstasia, Fall
Clinical narrative: I received the Hep A and Hep B vaccine around 5pm. Hep A was in the Right arm and Hep B was in the left arm. Also got a PPD in left forearm.The nurse who gave me the vaccines was very thorough - I commented on it to her - she checked and rechecked the vaccine bottles before drawing them up and administering them to me. I did not feel good after the vaccines, but that was to be expected. Wed (next day) I just did not feel good at all. That afternoon I started having bad aches on and off, but I just ignored them. Wed nite between 12am and 3am, I had a horrific pain to my mid spine area (like I had never had before- it woke me up) and it radiated around to my belly button and I had horrible abdominal pain in that area of my abdomen.  I remember thinking to myself - "Every fiber of my being hurts." AND, it was not like the flu, it was different, but hard to describe. I continued feeling very bad on Thursday and called out of work for the first 12 hrs of my shift. I was hoping to get better and go in the last 12 hrs.  Again, I cannot describe how horrible I Felt. Thursday nite about 4am, I got out of the bed to go to the bathroom and could not stand up. At first my head spun a little bit, but then stopped. (Note - I am used to getting up quickly and abruptly out of bed ALL the time with my job.) As I tried to walk, I fell to the left and could not walk. My husband heard me banging around falling on things and woke up. I said I cant walk right. He had to help me to the bathroom and back. I was concerned that I might be having a stroke and did the stroke scale tests. I passed them, but was still concerned what if this was just the early stages and I didnt want to miss that 3-4 hr window of getting to the hospital. I consulted a friend, an NP and she suggested I go to the hospital. I told her I owed the hospital enough and unless I was sure I was having a stroke I would rather not go. We talked about it more and decided it was not a stroke. I kept watch and tried to walk after that and it got better. I still could not walk straight. I felt sure it wasnt a stroke and therefore went to sleep. I woke up the next morning and a small amount of it was still there and called out the last 12 hrs of my shift. I was told I could take a benedryl and it may help, so I did and went bk to sleep. By the next morning I was doing much better all the way around.  I noticed I was a little weak when I tried to do alot, but otherwise I was ok.  NOTE: A co-worker of mine, who is in school stated he also has taken the Hep B vaccine a couple of times and he had the same horrific pains that I did. He did not have the Vertigo or inability to walk that I did.