chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) via a Pfizer sales representative. A 65-year-old patient of unspecified race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in Jul2015, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at injection site and limitation of arm movement both in Jul2015 with outcome of recovered after 12-24 hours.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from contactable pharmacist communicated through a Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in 2016 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever after receiving the vaccine in 2016 with outcome of unknown.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Cardio-respiratory arrest
Clinical narrative: Patient presented to ED on 5/6/2017 in cardio-respiratory arrest.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swelling at injection site immediately following injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Oedema, Swelling
Clinical narrative: Severe Swelling, Edema, Cellulitis.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Heart rate increased, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Body ache all over and pain. The next day bad muscle aches hurt to move pain meds did not help. 3rd day after shot big lump at injection site, hives, muscle aches improved. 4th day after shot little sleep, palm sized red and hot at shot region 9 inches long, hangover type headache. 5th day after shot no sleep, restlessness at bedtime. Day after shot rapid heartbeat in morning, pain and itching at injection site, Raynaud's feeling in fingers.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pruritus, Injection site warmth, Myalgia, Pain, Raynaud's phenomenon
Clinical narrative: Body ache all over and pain. The next day bad muscle aches hurt to move pain meds did not help. 3rd day after shot big lump at injection site, hives, muscle aches improved. 4th day after shot little sleep, palm sized red and hot at shot region 9 inches long, hangover type headache. 5th day after shot no sleep, restlessness at bedtime. Day after shot rapid heartbeat in morning, pain and itching at injection site, Raynaud's feeling in fingers.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Restlessness
Clinical narrative: Body ache all over and pain. The next day bad muscle aches hurt to move pain meds did not help. 3rd day after shot big lump at injection site, hives, muscle aches improved. 4th day after shot little sleep, palm sized red and hot at shot region 9 inches long, hangover type headache. 5th day after shot no sleep, restlessness at bedtime. Day after shot rapid heartbeat in morning, pain and itching at injection site, Raynaud's feeling in fingers.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site rash, Myalgia
Clinical narrative: Body ache all over and pain. The next day bad muscle aches hurt to move pain meds did not help. 3rd day after shot big lump at injection site, hives, muscle aches improved. 4th day after shot little sleep, palm sized red and hot at shot region 9 inches long, hangover type headache. 5th day after shot no sleep, restlessness at bedtime. Day after shot rapid heartbeat in morning, pain and itching at injection site, Raynaud's feeling in fingers.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pain, Pain
Clinical narrative: Patient had redness, pain, and inflammation at the site of immunization. Stated that the burning/pain began immediately after receiving the shot and the swelling began the following day was seen by MD and given Hydrocortisone 25% cream and cephalexin 500mg. Has been Improving
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient had redness, pain, and inflammation at the site of immunization. Stated that the burning/pain began immediately after receiving the shot and the swelling began the following day was seen by MD and given Hydrocortisone 25% cream and cephalexin 500mg. Has been Improving
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Back pain
Clinical narrative: Pt got vaccine 5/8/17. Developed low back pain that night.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Hypoaesthesia, Loss of consciousness, Middle insomnia, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: C/O new onset seizures. Received HPV vaccine 4/20/2017. 3 days later started having symptoms of stiffness/cramping with numbness on (R) side (neck, arm, leg) that happened mostly all day but lasted few minutes. Patient seen at ER 5/7 and came to our office for F/U 5/6/2017. Informant Mother and Father. Pt. here with both parents, from hospital with C/O new onset seizures. Pt. received HPV vaccine 4/20/2017, 3 days later started having symptoms of stiffness/cramping with numbness sensation only on right side (neck, arm and leg) that happened mostly all day but lasted only few minutes, worse at night and often woke up at night with these symptoms. Pt. had started swimming 1 month ago and Mom thought it was due to exercising. No other illnesses noted. Pt. seen at ER on 5/7 since while sleeping was noted to be stiff and shaking (brother woke up since bed was shaking at night). Pt. had LOC, unclear how long, but woke up 3-4 mins later and was very pale and EMS was contacted. Did not have Neuro eval but was placed on DILANTIN, pt. is supposed to return to ER for this AM dose since pharmacy was unable to fill script and has been seizure free on med. Does have pending appt. with neuro Fri. but parents concerned since no meds. C/O sore throat and sinus congestion currently and was given Amox. from hosp. but pharmacy did not dispense that either.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Oropharyngeal pain, Pallor, Seizure, Sinus congestion, Tremor
Clinical narrative: C/O new onset seizures. Received HPV vaccine 4/20/2017. 3 days later started having symptoms of stiffness/cramping with numbness on (R) side (neck, arm, leg) that happened mostly all day but lasted few minutes. Patient seen at ER 5/7 and came to our office for F/U 5/6/2017. Informant Mother and Father. Pt. here with both parents, from hospital with C/O new onset seizures. Pt. received HPV vaccine 4/20/2017, 3 days later started having symptoms of stiffness/cramping with numbness sensation only on right side (neck, arm and leg) that happened mostly all day but lasted only few minutes, worse at night and often woke up at night with these symptoms. Pt. had started swimming 1 month ago and Mom thought it was due to exercising. No other illnesses noted. Pt. seen at ER on 5/7 since while sleeping was noted to be stiff and shaking (brother woke up since bed was shaking at night). Pt. had LOC, unclear how long, but woke up 3-4 mins later and was very pale and EMS was contacted. Did not have Neuro eval but was placed on DILANTIN, pt. is supposed to return to ER for this AM dose since pharmacy was unable to fill script and has been seizure free on med. Does have pending appt. with neuro Fri. but parents concerned since no meds. C/O sore throat and sinus congestion currently and was given Amox. from hosp. but pharmacy did not dispense that either.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61-year-old male patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On 12-APR-2017, the patient was vaccinated with ZOSTAVAX, lot # M035693 with expiry date on 07-NOV-2017 (dose and route of administration were not reported) for prophylaxis. On the same day, after the administration of ZOSTAVAX, the patient began to experience tingling at the injection site. No treatment was given for the event and no laboratory diagnostics studies were performed. The patient did not seek a medical attention. Product quality complaint (PQC) was not involved. The outcome of the event was reported as recovered on the same day. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-2017 the patient was vaccinated with with an expired dose of ZOSTAVAX lot # L037790 with an expiration date 30-DEC-2017 for prophylaxis (dose, route of administration, anatomical location were not reported). According to the reporter, administered dose of ZOSTAVAX did not experienced any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unspecified patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot number M020926, expiration date 11-AUG-2018 (dose and route were not reported) for prophylaxis. Temperature involved 47°F to 77°F for 4 hours. The temperature excursion reported was 32° F to 35° F for 41 minutes. A data logger was involved. No adverse event was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 61 year old female patient. The patient's medical history included convulsion when she had chickenpox at 9 months of age (29-JAN-1957). The patient had not drug allergies, and concurrent conditions were not reported. On 03-MAY-2017, the patient was vaccinated with ZOSTAVAX subcutaneously at the left arm, lot number M037655, expiration date 29-NOV-2017 (dose was not reported) for previous history of chickenpox (prophylaxis). Another suspect therapy included sterile diluent (dose, route, lot number and expiration date were not reported). On an unspecified date in May 2017, the patient's injection site became warm and "enlarged". It was reported, that the patient received an unspecified treatment for the events. The reporter was going to contact the patient on 08-MAY-2017 to inquire about her status. At the time of reporting, the outcome of the events was unknown. The causal relationship between the events and ZOSTAVAX and sterile diluent was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M039316, expiration date 20-SEP-2018, lot # M041513, expiration date 11-OCT-2018 and lot # L040419, expiration date 14-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Vaccines were reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. There were no previous excursions reported. Digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccines were reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red and swelling that begins at shoulder and goes all the way to her elbow- warm to the touch - Also when I called her back she had chills.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Nausea
Clinical narrative: Patient complained of nausea and swelling to her right deltoid. Offered appointment to evaluate but the patient denied.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Papule, Rash generalised, Rash papular, Rash vesicular
Clinical narrative: 4/26/2017: large vesicular-like lesions on proximal aspect BUES extensor surface with multiple erythematous satellite papules, similar lesions on proximal aspect BLES, no drainage or discharge noted. Start BACTROBAN cream 2% 3 times a day 10 days. 4/28/2017: rash BUES and BLES, lesions more extensive. 5/9/2017: generalized papular rash scabbed over.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Scab
Clinical narrative: 4/26/2017: large vesicular-like lesions on proximal aspect BUES extensor surface with multiple erythematous satellite papules, similar lesions on proximal aspect BLES, no drainage or discharge noted. Start BACTROBAN cream 2% 3 times a day 10 days. 4/28/2017: rash BUES and BLES, lesions more extensive. 5/9/2017: generalized papular rash scabbed over.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Chills, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: ABDOMINAL PAIN, CHILLS, SWEATING, HOT, FELT VERY TIRED, TENDERNESS, HARD NODE ON VACCINE SITE.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Tenderness, Vaccination site induration, Vaccination site nodule
Clinical narrative: ABDOMINAL PAIN, CHILLS, SWEATING, HOT, FELT VERY TIRED, TENDERNESS, HARD NODE ON VACCINE SITE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: AT INJECTION SITE: REDNESS, SWELLING, ITCHING, BLISTERS, AND SEVERE PAIN TRAVELING DOWN LEFT ARM FROM SITE OF INJECTION.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itching on upper arm where injection was administered.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Abdominal discomfort, Feeling abnormal, Haematochezia, Haemorrhage, Infantile spitting up
Clinical narrative: Patient began screaming and you could tell his stomach was very uncomfortable. He then had a bloody stool and began spitting up frequently. He was not able to sleep longer than a few minutes at a time for several days. The bleeding subsided 2 weeks later, but he is still not his normal self.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Insomnia, Occult blood positive, Screaming
Clinical narrative: Patient began screaming and you could tell his stomach was very uncomfortable. He then had a bloody stool and began spitting up frequently. He was not able to sleep longer than a few minutes at a time for several days. The bleeding subsided 2 weeks later, but he is still not his normal self.
Sex: U
Vaccine: PPV
Symptoms: Chest pain, Injection site reaction, Muscle spasms
Clinical narrative: This information has been received from a Licensed Practical Nurse and administrator concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 lot # M038359 and expiration date on 13-MAY-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. On an unknown date, the patient experienced muscle spasm at the injection site (on an unspecified arm) and also had complaint of chest pain. The patient was taken to the emergency room at an unspecified hospital and received treatment for the events. The outcome of muscle spasm at the injection site and chest pain and the causal relationship between the events and therapy with PNEUMOVAX23 were not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA003937.
Age: 81.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 27-APR-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB intramuscularly, expiration date on 15-APR-2017 (strength, dose number, anatomical location and lot number were not provided) for prophylaxis. No adverse event reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 78 year-old female patient, allergic to SEPTRA. Her concurrent conditions included celiac disease. There were no historical conditions reported and the patient's concomitant therapies included unspecified vitamins. On 04-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection (dose, frequency and route were not reported) lot # M039060 with expiration date of 22-MAY-2018, for prophylaxis. On 05-MAY-2017, the patient developed cellulitis and experienced redness. The patient sought medical attention and treatment was given for the adverse event; no laboratory diagnostics studies were performed. At the time of the report, she had not recovered from the cellulitis. The causality between the adverse event and PNEUMOVAX23 was unknown. Upon internal review, cellulitis was considered to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Information has been received from a physician, referring to a 66 year old female patient with osteoporosis (since an unknown date). The patient's medical history was not reported. None concomitant therapies or drug reactions/allergies were reported. On 27-APR-2017, the patient was vaccinated with PNEUMOVAX23 lot # N003993, expiration date on 20-OCT-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. On 28-APR-2017, the patient was seen at the office for treatment of "severe swelling, and redness" to the" injection site and the entire arm." The patient received treatment with BENADRYL, KENALONG injection, REFLEX 500 mg every 6 hours, and prednisone (manufacturer unknown) 40 mg for 7 days. Approximately on 30-APR-2017 (reported as "2 days after treatment started"), the patient stated that she was better. It was reported that no lab diagnostics studies were performed. The reporting physician requested a lot check on this product. The causality between the vaccination with PNEUMOVAX23 and the events was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills
Clinical narrative: This spontaneous report was received from a physician concerning a 53 year old male patient. The patient's concurrent conditions included LGL T cell leukemia and chronic neutropenia. The patient's historical drugs and medical history were not reported. On 04-MAY-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for vaccination (prophylaxis). The patient's concomitant medication included hydrochlorothiazide. On the same date, the patient developed joint pain, rigors and possible cellulitis at the injection site. On an unspecified date in May 2017, the patient was admitted to a hospital where he was treated with unspecified antibiotics. No lab diagnostics studies were performed. On an unspecified date, the patient sought medical attention. At the time of reporting, the status of the patient was unresolved. The causal relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. A 66 year old female patient received, on 22Apr2017, PREVNAR 13 (Lot. N97936, Expiration date: Jan2018, NDC number: 00055197101, UPC number: 300051971022) single dose, for immunization. Relevant medical history included penicillin allergy, dental issue and blood pressure. Concomitant medications included Losartan 100 mg /HCTZ 12.5 mg for blood pressure (ongoing); and chlorhexidine for dental issue. On 23Apr2017, the patient experienced itchy skin on the arms. On an unspecified date, in Apr2017, the patient started to become red hot and swollen from shoulder to elbow. Treatment  with hydrocortisone cream was received. Clinical outcome of the events was recovering at time of this report.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable nurse reported through a Pfizer sales representative. The nurse reported for herself. A 58-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on Jul2015 for reduce incidence of pneumococcal infection. The patient medical history and concomitant medications were not reported. On Jul2015, the patient experienced pain at injection site and limitation of arm movement lasted 48-60 hours. She did not take any analgesic or have any further treatment. Final outcome of the events was recovered.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Tenderness
Clinical narrative: REDNESS, TENDERNESS, AND BRUISING FROM LOWER UPPER ARM TO MID FOREARM.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Erythema, Injection site pain, Local reaction
Clinical narrative: ERYTHEMA STARTED OFF MINIMAL AND GOT WORSE THROUGHOUT THE DAY. PAIN AT INJECTION SIGHT. DIAGNOSED WITH LARGE LOCAL REACTION SITE.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HBPV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Crying episode for >3 hours within 48 hours of vaccine.
Age: 0.42
Sex: F
Vaccine: DTAP
Symptoms: Autoimmune colitis, Blepharospasm, Crying, Immediate post-injection reaction, Injection site erythema
Clinical narrative: 1-Personality shift immediately from laughing and talking at 2pm to only crying, which was very unusual for her. Unexplained screaming fits lasted until 11/22 and first signs of talking again on 11/22. On 12/12 was the first sign of laughter again. Personality starting to come back. 2-The evening of the shot, 11/9 she developed a twitch where her head was sporadically twitching and tilting to the right side (ear to shoulder) looking like nerve damage. Lasting several days. 3-On 11/10 was a reaction at injection site. Swollen, red, hot and lump lasting until 12/5/16. 4-On 11/12 starting to throw up all day. No longer can take solids without throwing up. Believe to have triggered FPIES. Had no problem with the same food prior to shot. 5-Developed sporadic eye twitch in her right eye lasting until 12/26. Again same side as the previous head twitching. Again showing signs of damage to central nervous system and possibly brain. Could have been mild stroke.
Age: 0.42
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass, Injection site swelling, Injection site warmth, Muscle twitching, Nerve injury
Clinical narrative: 1-Personality shift immediately from laughing and talking at 2pm to only crying, which was very unusual for her. Unexplained screaming fits lasted until 11/22 and first signs of talking again on 11/22. On 12/12 was the first sign of laughter again. Personality starting to come back. 2-The evening of the shot, 11/9 she developed a twitch where her head was sporadically twitching and tilting to the right side (ear to shoulder) looking like nerve damage. Lasting several days. 3-On 11/10 was a reaction at injection site. Swollen, red, hot and lump lasting until 12/5/16. 4-On 11/12 starting to throw up all day. No longer can take solids without throwing up. Believe to have triggered FPIES. Had no problem with the same food prior to shot. 5-Developed sporadic eye twitch in her right eye lasting until 12/26. Again same side as the previous head twitching. Again showing signs of damage to central nervous system and possibly brain. Could have been mild stroke.
Age: 0.42
Sex: F
Vaccine: DTAP
Symptoms: Personality change, Posture abnormal, Screaming, Vomiting
Clinical narrative: 1-Personality shift immediately from laughing and talking at 2pm to only crying, which was very unusual for her. Unexplained screaming fits lasted until 11/22 and first signs of talking again on 11/22. On 12/12 was the first sign of laughter again. Personality starting to come back. 2-The evening of the shot, 11/9 she developed a twitch where her head was sporadically twitching and tilting to the right side (ear to shoulder) looking like nerve damage. Lasting several days. 3-On 11/10 was a reaction at injection site. Swollen, red, hot and lump lasting until 12/5/16. 4-On 11/12 starting to throw up all day. No longer can take solids without throwing up. Believe to have triggered FPIES. Had no problem with the same food prior to shot. 5-Developed sporadic eye twitch in her right eye lasting until 12/26. Again same side as the previous head twitching. Again showing signs of damage to central nervous system and possibly brain. Could have been mild stroke.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies/reactions or concomitant medications. On an unknown date, the patients were inadvertently vaccinated with improperly stored VARIVAX lot # M033907 with expiration date of 20-JUL-2018 and lot # M033214 with expiration date of 13-JUL-2018, subcutaneously, for prophylaxis (dose and route of administration were not reported); diluted in sterile water diluent, for prophylaxis (lot number and expiration date were not reported). No adverse effects reported. No additional information was provided. Administered doses of vaccines experienced the temperature excursion of 15-46 degrees Fahrenheit (27.6°F) for 2.5 hours. Data logger was not involved. There were previous excursions of 6-14 degrees Fahrenheit (12.8°F) for 1.5 hours. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA000321.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies/reactions or concomitant medications. On an unknown date, the patients were inadvertently vaccinated with improperly stored ZOSTAVAX lot # reported as M035697 with expiration date of 07-NOV-2017, for prophylaxis (dose and route of administration were not reported); diluted in sterile water diluent, subcutaneously, for prophylaxis (lot number and expiration date were not reported). No adverse effects reported. No additional information was provided. Administered doses of vaccines experienced the temperature excursion of 15-46 degrees Fahrenheit (27.6°F) for 2.5 hours. Data logger was not involved. There were previous excursions of 6-14 degrees Fahrenheit (12.8°F) for 1.5 hours. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA000311.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection for prophylaxis (lot # M025871 with expiration date: 24-MAY-2018 and lot #M038859 with expiration date: 14-SEP-2018; dose and frequency were not reported). No known adverse effects  were reported. Administered doses of VARIVAX underwent temperature excursions prior to being administered. The doses of the vaccine were exposed to a temperature of 6.8° degree Fahrenheit (F) for a time frame of 45 minutes and to 5.9° degree F for a time frame of 30 minutes. There were no previous temperature excursions. A digital data logger was involved. It was unknown how many patients received each of the vaccine lots listed above. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date in 2016 (reported as between May2016 and December 2016), the patient was vaccinated with improperly stored VARIVAX lot # L021214 with expiration date of 10-JUN-2017, for prophylaxis (dose and route of administration were not reported), reconstituted with properly stored sterile diluent (dose, route of administration, lot number and expiration date were not reported). The vaccine was exposed to a temperature excursion of 15-46 degrees Fahrenheit (°F) for 12 hours. There were previous excursions of 15-46 degrees Fahrenheit (°F) for 29 hours.  There was not data logger involved. No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001690: US-009507513-1705USA001693.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # M039202 with expiration date of 11-MAR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. Data logger was involved. There were not previous excursions. No adverse symptoms were reported. No other information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002222: US-009507513-1705USA002242: US-009507513-1705USA002243.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a 55 year old patient of an unknown gender. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On 04-MAY-2017, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # N005096 with expiration date of 22-OCT-2018, for prophylaxis (dose and route of administration were not reported). The vaccine was exposed to a temperature excursion of 28 degrees Fahrenheit (°F) for 12 hours. There were not previous excursions or data logger involved. No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 17 year old male patient. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date in August 2016, the patient was vaccinated with RECOMBIVAX HB (10/1.0 mcgr/ml), for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Brain injury
Clinical narrative: This initial spontaneous report was received from a pharmacist via a company representative referring to an unspecified amount of patients of unknown age and gender. On unspecified dates, the patients received ZOSTAVAX (lot # not provided). The pharmacist reported that unspecified patients had brain damage after receiving ZOSTAVAX. The outcome was unknown. Causality was not provided. Upon internal review, brain damage was considered medically significant. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: SEVERAL HOURS AFTER IMMUNIZATION PATIENTS ARM GOT SWOLLEN/HARD/PAINFUL AT INJECTION SITE. NO REDNESS OCCURRED.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant at time of vaccination. She indicated to HCP administering that she was not.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient got lightheaded and passed out after the vaccine was administered and was ok after that.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Flushing, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Patient fainted immediately on giving the GARDASIL-9 vaccine. Unresponsive for only a few seconds. Had flushing and dizziness. Sat in chair for about 15 minutes and recovered.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Patient is new to Medical Center. He declined influenza vaccine as he had nausea and vomiting in the past. It is unknown to provider when this side effect occur and at that time who prescribed influenza vaccine to patient. Since patient stated he had adverse event from influenza vaccine PCP enter as allergy into system.
Age: 11.0
Sex: M
Vaccine: MMRV, MMRV, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction, MMR was given instead of Meningococcal, patient had had 2 doses of MMR on 5-10-17 and 3-12-10. Third dose wasn't needed (PROQUAD).
Age: 11.0
Sex: M
Vaccine: MMRV, MMRV, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction, MMR was given instead of Meningococcal, patient had had 2 doses of MMR on 5-10-17 and 3-12-10. Third dose wasn't needed (PROQUAD).
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Client 2 yr. 8 month was given Flu vaccine for 3yr old. No adverse reaction reported.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site nodule, Injection site rash, Injection site warmth
Clinical narrative: Developed a knot and a rash with fever at injection site of either varicella or Hep A, one week after receiving vaccines. Rash was raised and rough but no vesicles. Suspect its a vigorous response to the vaccine.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 15-year-old male patient who received BEXSERO. On 20th April 2015, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. In April 2015, less than a week after receiving BEXSERO, the patient experienced swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm  and injected limb mobility decreased were unknown. It was unknown if the reporter considered the swelling arm and injected limb mobility decreased to be related to BEXSERO. Additional details provided as follows: The healthcare provider reported to a sales representative that their patient called the his office 5 days of receiving a BEXSERO injection, he had swelling in his right arm (same arm of BEXSERO injection) and he was unable to move his arm. The healthcare provider advised the patient to go to the emergency room. No further details available at this the reporting time. It was unknown if patient had any concomitant or recent vaccines and or previous allergy history to any vaccines. Limited information was provided by the representative, the lot and expiration date of the vaccine was not available as well as the time of injection, onset of the start of the event post injection, unknown if the symptoms resolved or if the patient had died, hospitalized, or if event was disabling.
Age: 56.0
Sex: M
Vaccine: MEN
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: For about 3 days there were soreness in my arms. Then there were a pain for about a week. Now a little weakness when I lift something or have my arm a certain way.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site bruising
Clinical narrative: Right thigh and left thigh contusion. Rx: warm compress and TYLENOL PM.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Rash, Respiratory tract congestion
Clinical narrative: Skin rash and headache, congestion. Treatment: Diphenhydramine 25 mg QID, acetaminophen 650 mg BID.