chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Myalgia, Neck pain
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's coexisting conditions included rheumatoid arthritis with an unspecified onset. No other information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 06-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # L035686, expiration date 16-FEB-2017 (dose and anatomical location were not provided). On approximately 06-JUN-2016 (reported as immediately after receiving the PNEUMOVAX 23, the patient experienced a reaction described as: swelling, muscle pain, headache, neck ache, injection site swollen to size of orange (diagnosed as symptoms of cellulitis). The nurse reported that the patient sought medical attention by calling nurse practitioner office on 09-JUN-2016 but was not seen by the nurse practitioner until 10-JUN-2016 (also reported as today). The treatment note was not completed at the time of the call (reported as the patient was given the treatment). During infusion of REMICADE for rheumatoid arthritis on an unspecified date in June 2016, the unspecified staff member noticed that the patient had a hard area which was bruised and tender where the PNEUMOVAX 23 was administered. The patient did not have lab diagnostic studies performed. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's coexisting conditions included rheumatoid arthritis with an unspecified onset. No other information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 06-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # L035686, expiration date 16-FEB-2017 (dose and anatomical location were not provided). On approximately 06-JUN-2016 (reported as immediately after receiving the PNEUMOVAX 23, the patient experienced a reaction described as: swelling, muscle pain, headache, neck ache, injection site swollen to size of orange (diagnosed as symptoms of cellulitis). The nurse reported that the patient sought medical attention by calling nurse practitioner office on 09-JUN-2016 but was not seen by the nurse practitioner until 10-JUN-2016 (also reported as today). The treatment note was not completed at the time of the call (reported as the patient was given the treatment). During infusion of REMICADE for rheumatoid arthritis on an unspecified date in June 2016, the unspecified staff member noticed that the patient had a hard area which was bruised and tender where the PNEUMOVAX 23 was administered. The patient did not have lab diagnostic studies performed. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest discomfort, Cough, Dyspnoea, Eyelid oedema, Injection site erythema
Clinical narrative: Patient stated she experienced eyes swelling shut, itchy throat and roof of mouth, swelling to the inner portion of her mouth with some difficulty breathing, coughing, chest tightness. Localized reaction to injection site at left arm of redness and swelling with warmth to touch x3 days. Patient phoned emergency room and was advised to use benadryl for treatment.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Mouth swelling, Oral pruritus
Clinical narrative: Patient stated she experienced eyes swelling shut, itchy throat and roof of mouth, swelling to the inner portion of her mouth with some difficulty breathing, coughing, chest tightness. Localized reaction to injection site at left arm of redness and swelling with warmth to touch x3 days. Patient phoned emergency room and was advised to use benadryl for treatment.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Throat irritation
Clinical narrative: Patient stated she experienced eyes swelling shut, itchy throat and roof of mouth, swelling to the inner portion of her mouth with some difficulty breathing, coughing, chest tightness. Localized reaction to injection site at left arm of redness and swelling with warmth to touch x3 days. Patient phoned emergency room and was advised to use benadryl for treatment.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain in extremity
Clinical narrative: Arm pain, swelling and redness at injection site. Feeling "sick".
Age: 57.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: There were no adverse events. Client is on CELLCEPT for treatment of cicatricial alopecia. Was given live oral typhoid vaccine while on immunosuppressing drug. Took first capsule-had no problems. Stopped after capsule 1.
Sex: U
Vaccine: HPV4
Symptoms: Malaise, Nervous system disorder, Seizure
Clinical narrative: This solicited report has been received from a patient's mother, as part of a marketing research program, refers to an unknown number of patients (age and gender were not reported), which were the kids of the reporter's friends. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose, route and anatomical location of administration were not reported). On an unknown date, the patients got very sick (malaise) after the vaccine administration, including, experienced violent seizures and neurological issues (Nervous system disorder). The reporter stated "I believed that most of the vaccines were important, however, I was worried that we gave too many of them at once". The reporter also stated that she had not done the HPV vaccine (manufacturer unknown) yet, as she had heard too many negative things about them. The outcome of the event was not reported. The causality between Seizure, malaise and Nervous system disorder and therapy with GARDASIL was not reported. Upon internal review, Seizure was considered medically significant. Additional information is not expected as the reporter did not consent for further follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # L020162, expiration date 23-JUL-2017; Lot# was reported as L032181, expiration date was reported as 25-AUG-2017; Lot# was reported as L043702, expiration date was reported as 03-NOV-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. Information on patient's concurrent conditions, medical pertinent history and drug reactions was not provided. On 23-DEC-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, anatomical location, lot # and expiration date not provided). Concomitant medications were not provided. Subsequently, on 23-FEB-2016, the patient was vaccinated with a dose of GARDASIL. However, no adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L050956, expiration date 17-DEC-2017; lot # L045954, expiration date 17-NOV-2017; lot # M000760, expiration date 06-JAN-2018, route and dose were not reported). The vaccines were exposed to 6 F for 5 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX, lot # L030158/expiration date-11-AUG-2017 and lot no. L041205/expiration date-20-OCT-2017. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. Information about the patients' pertinent medical history and drug reactions/allergies was not reported. It was reported that since 16-MAY-2016, the patients' were vaccinated with improperly stored doses of VARIVAX, lot # M000760 with expiration date 06-JAN-2018, (dose, frequency and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. The VARIVAX was exposed to a temperature of 21 F for 63.5 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with three doses of GARDASIL (doses, route of administration, lot numbers and expiration dates were not reported). On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported). There was no adverse event reported. Additional information is not expected because there was no consent to contact physician assistant.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Rec'd. dose #3 GARDASIL (HPV-9) at WCE in office on 6-10-16. Woke next A.M. with c/o SA/stomach 'cramps'/and redness with edema and induration with warmth to (L) arm. Tx'd at home with BENADRYL. Seen for F.U. in office 6-13-16. S/S now nearly resolved and returned to WNL.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to 6 patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB strength reported as 2.5/0.5 (units not provided) (lot # L033343, expiration date: 13-SEP-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 51.4 degrees Fahrenheit for 2 hours. Data logger was not involved and there was no previous temperature excursion. The vaccine storage was back in appropriate range. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant 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 17-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# M004116, expiration date 12-OCT-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported and there was no previous temperature excursion. The data logger was involved. Temperature was 21.1 Fahrenheit for 2 hours and 5 minutes, 33.4 Fahrenheit for 6 hours and 5 minutes and 31 Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Crying, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer who was patient's mother regarding her daughter a 2 year old female patient. There was no information about concurrent condition and historical medication. On an unknown date in July 2014, the patient was vaccinated with PEDVAXHIB dose 1 in the unspecified leg. The second dose was administered in September 2015 when she was 4 months old. A third dose was administered to the patient when she was 8 months old. The patient was behind on her booster and for an unspecified reason. No concomitant medication was reported. On an unknown date in July 2014 the patient experienced prolonged crying which lasted for 3 hours after receiving the first dose of PEDVAXHIB. On unknown date after the booster dose the patient experienced some swelling around injection site. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. Patient spoke to unspecified nurse to seek medical attention. No PQC (product quality complaint) was involved. Action taken with PEDVAXHIB was reported as dose not changed. The outcome of prolonged crying was reported as resolved. The outcome of swelling around injection site and second dose administered in September of 2015 when she was 4 months old, third dose when she was 8 months old and behind on her booster was unknown. Additional information is not expected as physician does not wants to get contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unknown number of patients of unknown age and gender. Information about the patients' pertinent medical history and drug reactions/allergies was not reported. It was reported that since 16-MAY-2016, the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as K025764 with expiration date 08-JUN-2016, lot # L050907 with expiration date 14-JUN-2017 and lot # M001152 with expiration date 05-JUL-2017, (dose, frequency and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. The PROQUAD was exposed to a temperature of 21F for 63.5 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # was reported as M005727, expiration date was reported as 03-MAY-2017, route and dose were not reported). The vaccines were exposed to 6 F for 5 minutes without previous excursion. The issue was due to data logger. No symptoms were reported This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Body temperature increased, Extra dose administered
Clinical narrative: I called mom at 4:35 pm on 6/7/16 to follow-up on any adverse reactions. Mom said there are no symptoms out of the norm: "Temperature was under 101F." Symptom appeared a few hours after vaccination of having both MMRV and VARIVAX together and later subsided. Mom had no concerns while on the phone.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: High fever of 101.7, chills, extreme muscle pain throughout entire body.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: High fever of 101.7, chills, extreme muscle pain throughout entire body.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Urine analysis normal
Clinical narrative: High fever of 101.7, chills, extreme muscle pain throughout entire body.
Age: 10.0
Sex: M
Vaccine: DTAP, HEP, HEPA, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Dtap given, should have been given a Td due to age of patient (10 yo).
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Erythema and induration at injection site (LUE bicep) as well as circumferential UE edema around bicep.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Back pain, Dyspnoea, Gait disturbance, Headache
Clinical narrative: Severe headache on the way home from the office. Patient slept for 1 hour awoke with severe back pain and difficulty moving her legs. Mom gave Tylenol. 30 minutes later severe pain persisted accompanied by shortness of breath, gasping for air and numbness in hands. 911 was contacted. Patient was given pain medication in the ER and monitored. She was discharged home later in the evening. Hip and back pain continue but was well enough to attend school today (6/14).
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Severe headache on the way home from the office. Patient slept for 1 hour awoke with severe back pain and difficulty moving her legs. Mom gave Tylenol. 30 minutes later severe pain persisted accompanied by shortness of breath, gasping for air and numbness in hands. 911 was contacted. Patient was given pain medication in the ER and monitored. She was discharged home later in the evening. Hip and back pain continue but was well enough to attend school today (6/14).
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Upper right arm at injection site, developed elongated red, hot welt in diameter 6" x 3 inches". Showed for 3 to 4 weeks. Now at 6 weeks, size reduced to 2" x 1".  Still visible. No itching, or illness.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Within 3 hours of PNEUMOVAX administration patient developed erythema, edema and pain at injection site.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper arm redness, swelling and warm to touch also itchy and tender. Treated for cellulitis with oral antibiotic ordered 6/14/16 when pt 1st reported problem.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site warmth
Clinical narrative: Left upper arm redness, swelling and warm to touch also itchy and tender. Treated for cellulitis with oral antibiotic ordered 6/14/16 when pt 1st reported problem.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: After vaccine administration, pt. developed redness and itching at site and 1 hive noted at MMR site. 8 mL BENADRYL given in office. 20 minutes after BENADRYL, hive resolved and redness and itching improved.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of female patients of unknown age via a market research program. The patients' medical history was not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, lot number and route of administration not provided). The reported stated that the patient contracted human papillomavirus (HPV) but had been previously vaccinated. The outcome of Human papilloma virus infection was unknown. The relationship between vaccination with GARDASIL and the event was unknown (also reported as not applicable). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site mass, Injection site reaction, Injection site swelling
Clinical narrative: Patient had an adverse reaction at the injection site.  The injection site formed a purplish lump. The deltoid muscle in her left arm was swollen around the injection site.
Age: 82.0
Sex: M
Vaccine: HEPAB
Symptoms: Peripheral swelling
Clinical narrative: Patient says hand is swelling slightly, told him to watch it since it didn't look red and the injection site looked fine. Patient said he felt fine but there was slight swelling
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness, limited mobility in left arm.
Age: 2.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Blister, Pyrexia, Seizure, White blood cell count increased
Clinical narrative: Child developed rapid onset fever with seizures x 2. Treated with Omnicef. She had another seizure with fever spike on 6/11/16.  Medication changed to Amoxil at f/u visit on 6/13/16.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient came to pharmacy on this date and time with light headache, fever, chills and redness/swelling at injection site.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced injection site reactions. Bruising at injection site of Prevnar13. Redness, swelling, warmth, itching at injection site of Zostavax. Patient reported to pharmacy on 6/14/16 and brusing still present as well as redness/itching. Patient was treated with cold compress and Benadryl cream.
Age: 18.0
Sex: M
Vaccine: MNQHIB
Symptoms: Diarrhoea, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Patient started throwing up around 9:30 am. (shot was given around 8:30am)  He felt nauseous at 9am.  We got home, and he started to feel more and more ill, and was throwing up every 20 min or so.  He was very irritable and restless.  After a few hours, I didn't like that he was throwing up so much, so I brought him to the E.R.  He was throwing up there also, at this time it was 5pm.  Doctor gave him Zofran, and he felt better.  Could now drink and keep it down, and wasn't so ill.  We went home and he developed a fever that he didn't have. Also had diarrhea.  At one point it was 102.6.  So we gave him Tylenol every 6 hours, and that seemed to help.  It wasn't until about 10am the next day that he started to feel better and the fever went down.  It is 7:30 pm 6-14, and he is lying in bed achy and tired, but he has eaten a little and he is drinking and keeping it down.  This vaccine made him very ill, and if he didn't need it for college to live in the dorm, I wouldn't do it.  Scared the heck out of me!!  I also hear that another girl who is a friend of my son's is also sick right now.  It seems odd that two kids in the same area get pretty sick from this.  I hope someone checks out this shot that was administered.
Age: 18.0
Sex: M
Vaccine: MNQHIB
Symptoms: Pyrexia, Restlessness, Vomiting
Clinical narrative: Patient started throwing up around 9:30 am. (shot was given around 8:30am)  He felt nauseous at 9am.  We got home, and he started to feel more and more ill, and was throwing up every 20 min or so.  He was very irritable and restless.  After a few hours, I didn't like that he was throwing up so much, so I brought him to the E.R.  He was throwing up there also, at this time it was 5pm.  Doctor gave him Zofran, and he felt better.  Could now drink and keep it down, and wasn't so ill.  We went home and he developed a fever that he didn't have. Also had diarrhea.  At one point it was 102.6.  So we gave him Tylenol every 6 hours, and that seemed to help.  It wasn't until about 10am the next day that he started to feel better and the fever went down.  It is 7:30 pm 6-14, and he is lying in bed achy and tired, but he has eaten a little and he is drinking and keeping it down.  This vaccine made him very ill, and if he didn't need it for college to live in the dorm, I wouldn't do it.  Scared the heck out of me!!  I also hear that another girl who is a friend of my son's is also sick right now.  It seems odd that two kids in the same area get pretty sick from this.  I hope someone checks out this shot that was administered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Influenza like illness, Nausea, Peripheral swelling
Clinical narrative: Swelling of arm, severe redness, rash, fever, flu-like symptoms, nausea, headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Swelling of arm, severe redness, rash, fever, flu-like symptoms, nausea, headache.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Leukocytosis, White blood cell count increased
Clinical narrative: Pt received 4 month vaccinations - including Rotavirus and patient had watery diarrhea and leukocytosis up to 32.3. Pt was hospitalized at hospital.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site swelling, Peripheral swelling, Respiratory distress
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a 17-year-old male patient who received BEXSERO. On 3rd June 2016, the patient received BEXSERO .5 ml. On 3rd June 2016, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant and other: As per reporter), injection site swelling (serious criteria other: as per reporter), respiratory distress (serious criteria GSK medically significant and other: As per reporter), difficulty breathing (serious criteria other: as per reporter) and wheezing (serious criteria other: as per reporter). The patient was treated with EPIPEN and medication unknown (Nebulizer (Name Unknown)). On 5th June 2016, the outcome of the respiratory distress and wheezing were recovered/resolved. On an unknown date, the outcome of the anaphylactic reaction, injection site swelling and difficulty breathing were recovering/resolving. The reporter considered the anaphylactic reaction, injection site swelling, respiratory distress, difficulty breathing and wheezing to be related to BEXSERO. Additional details were received as follows: The patient experienced what appeared to be similar to a latex anaphylactic reaction. The patient experienced breathing issues, swelling of the arm. The patient was treated with an EPIPEN and was taken to the emergency room. Once the patient arrived at the emergency room he was administered an additional EPIPEN. The patient experienced respiratory distress like symptoms and he could not breathe. The patient also received breathing treatments via a nebulizer. On 5th June 2016, the patient's mother called the health care provider and reported that the patients wheezing had subsided and the swelling in the arm was reduced.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Wheezing
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a 17-year-old male patient who received BEXSERO. On 3rd June 2016, the patient received BEXSERO .5 ml. On 3rd June 2016, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant and other: As per reporter), injection site swelling (serious criteria other: as per reporter), respiratory distress (serious criteria GSK medically significant and other: As per reporter), difficulty breathing (serious criteria other: as per reporter) and wheezing (serious criteria other: as per reporter). The patient was treated with EPIPEN and medication unknown (Nebulizer (Name Unknown)). On 5th June 2016, the outcome of the respiratory distress and wheezing were recovered/resolved. On an unknown date, the outcome of the anaphylactic reaction, injection site swelling and difficulty breathing were recovering/resolving. The reporter considered the anaphylactic reaction, injection site swelling, respiratory distress, difficulty breathing and wheezing to be related to BEXSERO. Additional details were received as follows: The patient experienced what appeared to be similar to a latex anaphylactic reaction. The patient experienced breathing issues, swelling of the arm. The patient was treated with an EPIPEN and was taken to the emergency room. Once the patient arrived at the emergency room he was administered an additional EPIPEN. The patient experienced respiratory distress like symptoms and he could not breathe. The patient also received breathing treatments via a nebulizer. On 5th June 2016, the patient's mother called the health care provider and reported that the patients wheezing had subsided and the swelling in the arm was reduced.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Feeling hot, Local reaction, Rubber sensitivity, Wheezing
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a 17-year-old male patient who received BEXSERO. On 3rd June 2016, the patient received BEXSERO .5 ml. On 3rd June 2016, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant and other: As per reporter), injection site swelling (serious criteria other: as per reporter), respiratory distress (serious criteria GSK medically significant and other: As per reporter), difficulty breathing (serious criteria other: as per reporter) and wheezing (serious criteria other: as per reporter). The patient was treated with EPIPEN and medication unknown (Nebulizer (Name Unknown)). On 5th June 2016, the outcome of the respiratory distress and wheezing were recovered/resolved. On an unknown date, the outcome of the anaphylactic reaction, injection site swelling and difficulty breathing were recovering/resolving. The reporter considered the anaphylactic reaction, injection site swelling, respiratory distress, difficulty breathing and wheezing to be related to BEXSERO. Additional details were received as follows: The patient experienced what appeared to be similar to a latex anaphylactic reaction. The patient experienced breathing issues, swelling of the arm. The patient was treated with an EPIPEN and was taken to the emergency room. Once the patient arrived at the emergency room he was administered an additional EPIPEN. The patient experienced respiratory distress like symptoms and he could not breathe. The patient also received breathing treatments via a nebulizer. On 5th June 2016, the patient's mother called the health care provider and reported that the patients wheezing had subsided and the swelling in the arm was reduced.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 month old male patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 09-JUN-2016 the patient was vaccinated with expired M-M-R II (dosing details were not reported) (lot # K007106, expiry date 16-MAY-2016) subcutaneously in the left leg (expired vaccine used) . The patient has not experienced an adverse events. There was no product quality company involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 12-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042265, expiration date: 26-OCT-2017, (administration, route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 31-MAY-2016 the patient was vaccinated with a dose of M-M-R II (therapy type rHA, lot # L043702, expiration date 03-NOV-2017, dose and route not reported). The vaccine was improperly stored under 50.1 Fahrenheit degree for 1 hour 43 minutes. No previous temperature excursion. Data logger was involved. No adverse event reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: Diffuse erythema, inflammation, itchy, warm to touch x 9 days - being treated with oral antihistamines and antibiotics for cellulitis. Started tx today.
Sex: F
Vaccine: FLUN3, HPVX
Symptoms: Death
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of HPV vaccine (manufacturer unknown) (dose, strength, route of administration, lot# and expiry date were not reported) and a dose of FLUMIST (dose, strength, route of administration, lot# and expiry date were not reported). It was reported that the patient went back to the physician office the same day of vaccination for an unspecified reason. The next day (date unspecified), the patient died. Cause of death was not reported. The causality between the suspect vaccines and the patient's death was not reported. Upon internal review the event was considered to be medically significant. This is one of several reports received from the same source. Additional information is not expected as there was no contact details provided.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Full body hives x 4 days. Began 48 hours after vaccines administered.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 05-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 10-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 60 year old female Registered Nurse (R.N.) concerning herself. The patient's pertinent history included a case of shingles over 10 years ago. There were no drug allergies/drug reactions. On 03-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (Lot # and dose were not reported). Concomitant therapies included metoprolol, calcium (unspecified), omega-3 marine triglycerides (fish oil) and vitamin C. On 03-JUN-2106, and within 1 hour of receiving the ZOSTAVAX, the patient experienced a reaction described as itching the size of a quarter at the injection site and a reddened area that was darker red in the center that was about 4cm with lighter color to the edges with a total area of 10 cm with induration. There were no vesicles present. The nurse sought medical attention by emailing an unspecified Nurse Practitioner (N.P.) on an unknown date. It was reported that the N.P. suggested using ZANTAC to lessen the reaction, however at the time of the report the nurse had not taken it. The unspecified N.P. also prescribed the following treatments that were administered by the nurse to herself: ice packs to the injection site, took unspecified dosage of BENADRYL and non-steroid anti-inflammatory medications as needed. There were no diagnostic laboratory tests performed. At the time of the report the outcome of the injection site pruritus, injection site induration and injection site erythema was not recovered. There was no overdose nor product quality complain involved. Additional information had been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pediatric dose given not adult dose on 5/11/16. No adverse rxn just not enough of dose.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Feeling hot, Hypoaesthesia, Palpitations, Paraesthesia
Clinical narrative: Pt. experienced s/sx of over heating, chest pain, palpations, tingling and numbness in the left arm for 45 min. after she received her first Hep. B vaccine on 5/06/16.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Anticonvulsant drug level below therapeutic, Generalised tonic-clonic seizure
Clinical narrative: Known seizure disorder well controlled with levetiracetam had grand mal seizure 3 days after TRUMENBA.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Cough
Clinical narrative: Pt called stating that he noticed a cough 3 days after getting PNEUMOVAX immunization.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 27-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot# L034370; expiration date: 08-AUG-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 04-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hour 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot# L042265; expiration date: 26-OCT-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates, the patients were vaccination with a dose of ZOSTAVAX subcutaneous injection (dose, route, anatomical location and lot # were not reported). Subsequently, on an unknown date, the patients developed unspecified "Injection site reactions" and "a swollen arm" (unspecified arm). At the time of the report, the outcome and the causality between the events and ZOSTAVAX were unknown. Additional information is not expected since the physician cannot be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 12-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L04226; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 13-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Blood pressure abnormal, Heart rate abnormal, Pallor, Syncope
Clinical narrative: Case number PHHY2012US058261 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 445766) on 09 Jul 2012. This case refers to a 19-year-old male patient whose medical history, past drugs, current condition and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M10124) intramuscularly on to left arm and ADACEL (batch number: C3947BA) and ENGERIX-B (batch number: AHBVB986BB) intramuscularly on to right arm on 19 Dec 2011. On the same date he became pale and then fainted approximately five minutes after last vaccine was given. He was laid down. His blood pressure was 124/71 (units not reported) and pulse rate was 70 (units not reported). He was given juice and crackers. After seven minutes his blood pressure was 131/78 (units not reported) and pulse rate was 80 (units not reported). The final outcome of the event was reported as complete recovery as of 19 Dec 2011.