chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (lot#, expiry date, dosing details, anatomical location, were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095: US-009507513-1708USA009095.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiry date, dosing details, anatomical location, route were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA010633:
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 22-AUG-2017 or 23-AUG-2017, the patient was vaccinated with the fourth dose of GARDASIL 9 by mistake. On 22-AUG-2017 or 23-AUG-2017, the patient was extra dose administered. On an unknown date, the patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of an unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9. On an unknown date, the patient experienced incorrect product storage. No adverse effects were reported. Temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 4 hours. Previous temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 1 hour. Data logger was involved.; Sender's Comments:  US-009507513-1708USA010558: US-009507513-1708USA010559:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of an unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # M013156 for prophylaxis. On an unknown date, the patient experienced incorrect product storage. No adverse effects were reported. Temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 4 hours. Previous temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 1 hour. Data logger was involved. Sender's Comments: US-009507513-1708USA010559: US-009507513-1708USA010541.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with multiple doses of VAQTA injection lot # N005274 and expiry date: 03-APR-2018, lot # N005796 and expiry date: 26-MAY-2018 (exact dose and route of administration were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit on an unspecified date, for a time frame of 134 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010162: US-009507513-1708USA010561.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional and refers to multiple patients of unknown age. On unknown dates, those patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M039060 for prophylaxis. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010566: US-009507513-1708USA006667.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional and refers to multiple patients of unknown age. On unknown dates, those patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA006667: US-009507513-1708USA010565.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with VARIVAX lot # N009767 for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates the patients experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010487.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Axillary pain, Decreased appetite, Feeling abnormal, Influenza like illness, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (a Pfizer Employee, working in Customer Service) reporting on behalf of her son. A 18-year-old male patient received the first dose of TRUMENBA on 17Aug2017, in left arm, at 0.5 ml single, for immunisation. The patient was coming back to college and wanted to get vaccinated before going back to school. No other vaccines were administered on the same date or within 4 weeks prior. Medical history, family history and concomitant medications were none. The patient had a lot of pain in his left arm where he received the product since 17Aug2017, flu like symptoms on 18Aug2017, general malaise on 18Aug2017 around 07:30 or 08:00, was feeling really lousy on 18Aug2017 around 09:00, had nausea on 18Aug2017 around 10:00 or 11:00 and could not even eat on 18Aug2017 around 10:00 or 11:00. His arm was killing him, describing the pain. His arm became more and more painful, down into his armpit. When he got home at around 22:00 he told he could not believe that the physician made him get this vaccine. While packing stuff to move he said his arm was killing him and pain was into his body. The pain he was experiencing was in his left arm where he received the product. The reporter thought initially that the patient's pain was typical after some shots but it got worse and worse. On 17Aug2017 night he took some acetaminophen. His arm still hurt him but it was not as bad or as prevalent.  He took also some ibuprofen (ADVIL) on 18Aug2017. On 18Aug2017 morning he woke up and was ok for a little while by mid morning he said he did not feel right. He had more flu like symptoms which were described as he was feeling really lousy, with nausea, general malaise, and could not even eat (he ate very little). He felt fluish, meaning flu like symptoms. No treatment other than acetaminophen and ibuprofen was given. He did eat a little more about an hour before the report, when he started feeling better. The patient was instructed to eat half a sandwich and maybe he would feel better. The patient had an MRI of his back with dye, back in the spring. He did not know results, thought it was fine. The events did not require a physician or ER visit. All the events resolved on 18Aug2017.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Nausea, Nuclear magnetic resonance imaging, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (a Pfizer Employee, working in Customer Service) reporting on behalf of her son. A 18-year-old male patient received the first dose of TRUMENBA on 17Aug2017, in left arm, at 0.5 ml single, for immunisation. The patient was coming back to college and wanted to get vaccinated before going back to school. No other vaccines were administered on the same date or within 4 weeks prior. Medical history, family history and concomitant medications were none. The patient had a lot of pain in his left arm where he received the product since 17Aug2017, flu like symptoms on 18Aug2017, general malaise on 18Aug2017 around 07:30 or 08:00, was feeling really lousy on 18Aug2017 around 09:00, had nausea on 18Aug2017 around 10:00 or 11:00 and could not even eat on 18Aug2017 around 10:00 or 11:00. His arm was killing him, describing the pain. His arm became more and more painful, down into his armpit. When he got home at around 22:00 he told he could not believe that the physician made him get this vaccine. While packing stuff to move he said his arm was killing him and pain was into his body. The pain he was experiencing was in his left arm where he received the product. The reporter thought initially that the patient's pain was typical after some shots but it got worse and worse. On 17Aug2017 night he took some acetaminophen. His arm still hurt him but it was not as bad or as prevalent.  He took also some ibuprofen (ADVIL) on 18Aug2017. On 18Aug2017 morning he woke up and was ok for a little while by mid morning he said he did not feel right. He had more flu like symptoms which were described as he was feeling really lousy, with nausea, general malaise, and could not even eat (he ate very little). He felt fluish, meaning flu like symptoms. No treatment other than acetaminophen and ibuprofen was given. He did eat a little more about an hour before the report, when he started feeling better. The patient was instructed to eat half a sandwich and maybe he would feel better. The patient had an MRI of his back with dye, back in the spring. He did not know results, thought it was fine. The events did not require a physician or ER visit. All the events resolved on 18Aug2017.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pustule
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. A patient of an unspecified age, gender, race and ethnicity received, on 17Aug2017, PREVENAR 13 intramuscularly, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. Nurse stated that the injection site was normal except for the front and back part of the patient's arm. On an unspecified date, in Aug2017, the front and back part of the patient's arm was red and had fluid filled pustules. They wanted to know if the patient can receive the PNEUMOVAX 23 subsequently, since she is allergic to the PREVNAR 13. Clinical outcome of the events was unknown at time of this report.
Sex: M
Vaccine: TDAP
Symptoms: Cough, Loss of personal independence in daily activities, Panic reaction, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a child male patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by the patient's mother. The age at the time of vaccination was not reported. The patient was forced to get the whooping cough vaccine when he changed schools. The reporter had to sign a paper acknowledging that she understood that there was a chance he might contract the disease from the vaccine. The reporter had no choice but to sign, as the school would not permit the patient to enter without being vaccinated. The patient was one of the few who got whooping cough from the vaccine. The patient missed 2 months of school. The reporter got whooping from the patient. The reporter missed a lot of work, but because the reporter owned the business she had to go to work sick for weeks. The reporter can remember how hard it was to get things done, even just go grocery shopping, because of the coughing fits, almost like convulsions, trying not to pee in pants, coughing so bad the reporter felt panicky. This case was linked to US2017GSK131351, reported by same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a child patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be related to BOOSTRIX. Additional details were provided as follows: The age at the time of vaccination was not reported. Few patients got whooping cough from the vaccine. This case is linked with US2017GSK129330, reported by same reporter.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Face injury, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: As soon as the shot was given my daughter said she felt sick at her stomach. We waited about 10 mintues while the doctor prepared the necessary papers for my daughter to turn in at school. This immunization was her 7th grade shots. As we were walking out of the clinic we might have got 20 feet when she completely passed out, which caused her to hit the right side of her face on the floor. I got the receptions attention and she helped me get my daughter back to the clinic. She started sweating profusely and had no color what so ever. The physician got her a bottle of water and wet towels to hold off her face and brow. After about another 10 minutes she regained some of her color and felt well enough to walk to my car. Wednesday after she got home everything she showed me arm that was swollen.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: As soon as the shot was given my daughter said she felt sick at her stomach. We waited about 10 mintues while the doctor prepared the necessary papers for my daughter to turn in at school. This immunization was her 7th grade shots. As we were walking out of the clinic we might have got 20 feet when she completely passed out, which caused her to hit the right side of her face on the floor. I got the receptions attention and she helped me get my daughter back to the clinic. She started sweating profusely and had no color what so ever. The physician got her a bottle of water and wet towels to hold off her face and brow. After about another 10 minutes she regained some of her color and felt well enough to walk to my car. Wednesday after she got home everything she showed me arm that was swollen.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours after injections (separated by >1 inch apart) Left arm from shoulder to elbow was very swollen, red, painful and hot all the way around arm not just at injection site.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site induration, Local reaction, Nausea
Clinical narrative: Patient developed a fever/chills, nausea, and vomiting within along with a significant local reaction ( 9 x 7 cm area of erythema/induration) at the injection site.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient developed a fever/chills, nausea, and vomiting within along with a significant local reaction ( 9 x 7 cm area of erythema/induration) at the injection site.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired flu shot.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Pt was given a dose of ROTATEQ that had expired on the previous day. No signs or symptoms of reaction occured. The dose was repeated with ROTARIX Lot # EY5F7 during the same visit.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Laboratory test, Pain
Clinical narrative: Went in for over 65 Pneumococcal Conjugate Vaccine, at the time of the shot I was in a lot of pain, around 4:00 p, the day of June 1, 2017. I was told that it may go away in a few days. I waited and it did not and then I went back to pharmacy, they said that would contact Program. I went to my Dr. office for pain and only had very limited results. Still in a lot of pain today. May not even be able to do my job for much longer.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Injection site paraesthesia, Musculoskeletal pain, Neck pain, Paraesthesia
Clinical narrative: Went in for over 65 Pneumococcal Conjugate Vaccine, at the time of the shot I was in a lot of pain, around 4:00 p, the day of June 1, 2017. I was told that it may go away in a few days. I waited and it did not and then I went back to pharmacy, they said that would contact Program. I went to my Dr. office for pain and only had very limited results. Still in a lot of pain today. May not even be able to do my job for much longer.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site with redness, warmth, induration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache
Clinical narrative: Recurrent and repeated left facial and head sharp strong pain for a second that comes and goes multiple times a day.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M038846 or lot # M040268. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of six reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005170: US-009507513-1708USA005168: US-009507513-1708USA005169: US-009507513-1708USA005167: US-009507513-1708USA001493.
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Blood pressure decreased, Heart rate decreased, Presyncope
Clinical narrative: This spontaneous report as received from a physician via filed representative concerning an 11 year old male patient. The patient's concurrent condition included asthma. No medical history and concomitant medications were reported. On 27-JUL-2017, the patient was vaccinated with GARDASIL 9 dose 1 (dosing details, lot#, expiry date and route were unknown) for prophylaxis.  On the same day, the patient was also vaccinated with diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (reported as TDAP (tetanus, diphtheria, and pertussis) vaccine) and meningococcal vaccine (unspecified) (reported as meningitis vaccine) (dosing details, lot#, expiry date and route were unknown) both for prophylaxis. On 27-JUL-2017, when the patient was leaving the physician's office he nearly fainted (but did not faint). The patient was back into a room and rested for fifteen minutes. While in the room resting the patient's pulse and blood pressure were taken and blood pressure and pulse did drop. No treatment was given for the events. The outcome of presyncope was unknown. The outcome of blood pressure decreased and heart rate decreased was considered as recovering since reported as "vitals were better". The physician was not going to go forward with the second dose of the GARDASIL 9 until Merck contacts the physician and gives the recommendation whether to give the second shot of GARDASIL 9 or not. Causality assessment was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, and allergy/drug reactions were reported. Approximately in 2017 (reported as between June 2017 and 21-AUG-2017), the patients were vaccinated with improperly stored VARIVAX lot # M027342 with expiry date: 01-JUN-2018, lot# M037643, expiry date: 01-SEP-2018 (dosing details, route, anatomical location were unknown) for prophylaxis. The vaccines were administered with sterile diluent that was properly stored (lot#, expiry unknown). It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 10 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010667: US-009507513-1708USA010668.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, and allergy/drug reactions were reported. Approximately in 2017 (reported as between June 2017 and 21-AUG-2017), the patients were vaccinated with improperly stored ZOSTAVAX lot # M038350 with expiry date: 06-DEC-2017 (dosing details, route, anatomical location were unknown) for prophylaxis. The vaccines were administered with sterile diluent that was properly stored (lot#, expiry unknown). It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 10 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010668: US-009507513-1708USA009612.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, and allergy/drug reactions were reported. Approximately in 2017 (reported as between June 2017 and 21-AUG-2017), the patients were vaccinated with improperly stored PROQUAD lot # N004631 with expiry date: 07-AUG-2018, lot # M041083 with expiry date: 04-APR-2018 (dosing details, route, anatomical location were unknown) for prophylaxis. The vaccines were administered with sterile diluent that was properly stored (lot#, expiry unknown). It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 10 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010667: US-009507513-1708USA009612.
Age: 18.0
Sex: F
Vaccine: HPVX, MENB, MNQ
Symptoms: Blood cholesterol increased, Feeling hot, Full blood count normal, Headache, High density lipoprotein increased
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (pediatrician and also the prescribing provider) reported that a 18-year-old female patient received TRUMENBA (lot S26962) on 09Aug2017 at 09:58, at 0.5 ml single, in left arm, for meningitis B prevention (immunization). On 09Aug2017 the patient also received the second dose of MENACTRA and HPV vaccine, both at 1 DF single, for immunization. Prior vaccinations given within 4 weeks were none, as per reporter awareness. The patient previously received the first dose of MENACTRA and HPV vaccine, both for immunization, on unspecified dates, without any adverse event. Medical history included just minor things like pharyngitis, colds, wheezing, that kind of stuff. Family history was none, as per reporter awareness. Concomitant medication were none, as per reporter awareness. On 09Aug2017 the patient experienced headache. On 14Aug2017 the patient experienced tingling, pins and needles feeling all over and was feeling hot. The patient had tingling all over, returned in a few days and the tingling had gone away. The patient returned to the office on 16Aug2017, but was not to be seen for the reported events as she returned to have blood work and to make sure she was not coming down with a virus or something else. She also returned to the office to have it documented that she did have reactions to the vaccine. The patient's mother picked up forms from the office and reported that the patient was doing much better. The reporting physician told to patient's mother that the events were transient and would go away. The events did not require an ER visit or a physician visit. On 16Aug2017 CBC test showed nothing abnormal. Other tests done on 16Aug2017 showed low vitamin D, high total cholesterol and high good cholesterol. Most of the labs were fine. The reporter mentioned that the patient's good cholesterol was a little higher than normal, so that could contribute to higher total cholesterol. Headache resolved on 10Aug2017. The other reported events were resolving at the time of report. The reporting physician considered the events as medically significant and was not sure if the patient's reactions were from TRUMENBA or not. The patient received previous doses of MENACTRA and HPV and did not have reactions to those, thus caller was thinking it may be TRUMENBA. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 18.0
Sex: F
Vaccine: HPVX, MENB, MNQ
Symptoms: Paraesthesia, Vitamin D decreased
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (pediatrician and also the prescribing provider) reported that a 18-year-old female patient received TRUMENBA (lot S26962) on 09Aug2017 at 09:58, at 0.5 ml single, in left arm, for meningitis B prevention (immunization). On 09Aug2017 the patient also received the second dose of MENACTRA and HPV vaccine, both at 1 DF single, for immunization. Prior vaccinations given within 4 weeks were none, as per reporter awareness. The patient previously received the first dose of MENACTRA and HPV vaccine, both for immunization, on unspecified dates, without any adverse event. Medical history included just minor things like pharyngitis, colds, wheezing, that kind of stuff. Family history was none, as per reporter awareness. Concomitant medication were none, as per reporter awareness. On 09Aug2017 the patient experienced headache. On 14Aug2017 the patient experienced tingling, pins and needles feeling all over and was feeling hot. The patient had tingling all over, returned in a few days and the tingling had gone away. The patient returned to the office on 16Aug2017, but was not to be seen for the reported events as she returned to have blood work and to make sure she was not coming down with a virus or something else. She also returned to the office to have it documented that she did have reactions to the vaccine. The patient's mother picked up forms from the office and reported that the patient was doing much better. The reporting physician told to patient's mother that the events were transient and would go away. The events did not require an ER visit or a physician visit. On 16Aug2017 CBC test showed nothing abnormal. Other tests done on 16Aug2017 showed low vitamin D, high total cholesterol and high good cholesterol. Most of the labs were fine. The reporter mentioned that the patient's good cholesterol was a little higher than normal, so that could contribute to higher total cholesterol. Headache resolved on 10Aug2017. The other reported events were resolving at the time of report. The reporting physician considered the events as medically significant and was not sure if the patient's reactions were from TRUMENBA or not. The patient received previous doses of MENACTRA and HPV and did not have reactions to those, thus caller was thinking it may be TRUMENBA. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: Fever to 40.1 degrees C approx. 20 hours after PENTACEL Vaccine. No additional symptoms.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Infection, Swelling
Clinical narrative: The patient presented with redness and swelling and visited her PCP and they found she had an infection and prescribed an Antibiotic. She was advised to stay at home and rest for one day.
Age: 14.0
Sex: M
Vaccine: IPV, MNQ, TDAP, VARCEL
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Client c/o constant pain in left arm from last injections on July 27, 2017. Left arm red and slightly swollen. Warm to touch. Denies recent injury to left arm. Referred to Urgent Care. Mother reported she will take client to Urgent Care today. Advise to bring clearance to receive IPV and MMR from doctor. Translator utilized. Mother and client demonstrated understanding.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Administered Hep A vaccine instead of Varicella. Client had no adverse reaction.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm red swollen and hot wrapping from back of arm to front.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Dysphagia, Palpitations, Swollen tongue
Clinical narrative: Within 10 minutes of receiving the vaccine I became very dizzy, noticed that I was having difficulty swallowing and my tongue was swelling. My heart felt like it was racing as well. I was treated at the onsite urgency center and given the following via an IV: Type 2 Diabetes, Essential Hypertension, Benign fasciculation cramp syndrome, dyslipidemia, Obesity, Vitamin D Deficiency, Stiff Person Syndrome and sent home with a prescription for a 7 day course of 4mg METHYLPREDNISolone 4 mg dose pk.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pain, Vomiting
Clinical narrative: The patient reported redness, inflammation, soreness at the injection site. She also experienced body aches and vomiting the day after the vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Nausea, Paraesthesia, Tinnitus
Clinical narrative: Patient began to feel nauseous within three minutes of the shot. She then felt dizzy after getting into the vehicle on her way to school. Then she had ringing in her ears and her vision went black and she appeared to pass out. Before she passed out, in an attempt to keep her awake we asked her to say the ABCs and she could not state them correctly. She also told us that when she passed out she felt tingly all over.
Age: 35.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Balance disorder, Dizziness, Hyperhidrosis, Hyporesponsive to stimuli, Mumps antibody test negative
Clinical narrative: Titers drawn for pre-placement showing inadequate immunity to Hepatitis B and Mumps. Advised to have booster doses of both, patient consented and provided with VIS which were read by patient and reviewed in detail prior to administration. Hepatitis B administered IM in left deltoid first, MMR administered SQ left posterior arm. After administration of both vaccines, patient was aox3, conversant, BP 117/85. Conversation continued with patient when suddenly he began to feel dizzy. He took a sip of water and became pale, diaphoretic. His hand was shaky and he seemed unsteady. His eyes were open but he maintained a distant gaze. He continued to be responsive non-verbally with hand cues to questions and remained in this state for approximately 3-5 minutes. An ice pack was applied to his neck and his immediate safety was maintained. He started to "come to" and his BP was measured as high 60s SBP. He continued to feel woozy but was verbally responsive at this point and able to drink water. His color began to return and he was more alert and responsive. We transferred him to the exam table where he was fully alert and BP was rechecked as 117/80. His wife came and he left ambulatory with steady gait accompanied by her.
Age: 35.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Pallor, Staring, Tremor
Clinical narrative: Titers drawn for pre-placement showing inadequate immunity to Hepatitis B and Mumps. Advised to have booster doses of both, patient consented and provided with VIS which were read by patient and reviewed in detail prior to administration. Hepatitis B administered IM in left deltoid first, MMR administered SQ left posterior arm. After administration of both vaccines, patient was aox3, conversant, BP 117/85. Conversation continued with patient when suddenly he began to feel dizzy. He took a sip of water and became pale, diaphoretic. His hand was shaky and he seemed unsteady. His eyes were open but he maintained a distant gaze. He continued to be responsive non-verbally with hand cues to questions and remained in this state for approximately 3-5 minutes. An ice pack was applied to his neck and his immediate safety was maintained. He started to "come to" and his BP was measured as high 60s SBP. He continued to feel woozy but was verbally responsive at this point and able to drink water. His color began to return and he was more alert and responsive. We transferred him to the exam table where he was fully alert and BP was rechecked as 117/80. His wife came and he left ambulatory with steady gait accompanied by her.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Body temperature increased, Culture throat negative, Dehydration, Full blood count normal, Headache
Clinical narrative: The patient is a healthy 48-year-old male with a history of adverse reaction characterized by severe myalgia and malaise with onset 3 hours after receipt of anthrax #4 on May 18 2016. He reports symptoms included headache nausea, vomiting and increased in severity over the next several hours and were very severe for 3 days and had a total duration of 5 days when symptoms resolved. He had difficulty performing required tasks for his pre deployment. He was seen in ER on 19 and 22 May. He had no previous issues with any vaccines or other doses of anthrax vaccine. He reports he had no immediate reaction and does not recall any urticaria, pruritus, oral facial throat or tongue swelling, flushing or watery eyes. ER note 19 May state dehydration and treated with Tylenol Motrin doxycycline zofran  ER note May 22 diagnosis pharyngitis, negative strep mild temperature elevation at 99.5 heart rate 96. Rx added cepacol.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Loss of personal independence in daily activities, Malaise, Metabolic function test normal, Myalgia, Nausea
Clinical narrative: The patient is a healthy 48-year-old male with a history of adverse reaction characterized by severe myalgia and malaise with onset 3 hours after receipt of anthrax #4 on May 18 2016. He reports symptoms included headache nausea, vomiting and increased in severity over the next several hours and were very severe for 3 days and had a total duration of 5 days when symptoms resolved. He had difficulty performing required tasks for his pre deployment. He was seen in ER on 19 and 22 May. He had no previous issues with any vaccines or other doses of anthrax vaccine. He reports he had no immediate reaction and does not recall any urticaria, pruritus, oral facial throat or tongue swelling, flushing or watery eyes. ER note 19 May state dehydration and treated with Tylenol Motrin doxycycline zofran  ER note May 22 diagnosis pharyngitis, negative strep mild temperature elevation at 99.5 heart rate 96. Rx added cepacol.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Pharyngitis, Urine analysis normal, Vomiting
Clinical narrative: The patient is a healthy 48-year-old male with a history of adverse reaction characterized by severe myalgia and malaise with onset 3 hours after receipt of anthrax #4 on May 18 2016. He reports symptoms included headache nausea, vomiting and increased in severity over the next several hours and were very severe for 3 days and had a total duration of 5 days when symptoms resolved. He had difficulty performing required tasks for his pre deployment. He was seen in ER on 19 and 22 May. He had no previous issues with any vaccines or other doses of anthrax vaccine. He reports he had no immediate reaction and does not recall any urticaria, pruritus, oral facial throat or tongue swelling, flushing or watery eyes. ER note 19 May state dehydration and treated with Tylenol Motrin doxycycline zofran  ER note May 22 diagnosis pharyngitis, negative strep mild temperature elevation at 99.5 heart rate 96. Rx added cepacol.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Fall, Head injury, Irritability, Loss of consciousness, Oedema
Clinical narrative: Following visit and vaccine administration, patient reportedly was standing at the front desk while mother was checking out, having calmed from the vigorous screaming during vaccines. Patient reportedly fell to the side, striking his head against a counter and then fell to the floor, losing consciousness for possibly 5 to most 10 seconds according to mother. Fine tremor/shaking occurred briefly according to mother, but no tonic-clonic activity. Aroused spontaneously with no evident postictal phase reported. No loss of bowel or bladder. Was subsequently returned to an exam room where he remained clingy to mother, continued to resist exam, but consolable.  Mother states he had not eaten in several hours, patient acknowledging he is hungry. Cardiovascular exam repeated, no abnormalities. Mild soft tissue edema occipital region corresponding to contact during fall, but no crepitus or other concerning features. Area measuring approximately 1.5 cm. Good muscle tone. Alert and responsive with no other concerning features. Discussed vasovagal episode, which certainly seems most likely here. Reviewed concerning symptoms in general for seizures or other concerning problems. Call if unexpected other issues. Mother acknowledges understanding.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Lethargy
Clinical narrative: Inconsolable crying for 48 hours and then lethargy for another 24 hours.
Age: 20.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MNQ
Symptoms: Disorientation, Dizziness, Feeling abnormal, Loss of consciousness, Muscle rigidity
Clinical narrative: Client was given Hep A & B vaccines in left deltoid, with no concerns. Client then given HPV in right deltoid. As this RN was just starting to give the Meningococcal he stated that he was feeling lightheaded. Seconds after the 4th (mening) was given, he stated that he felt horrible and went pale, then slumped, then he became rigid and his entire body started to shake almost as if he was starting a seizure. These events lasted approximately 1-2 minutes. Help was called to the room, client slumped in his chair and lost consciousness, which lasted 30 seconds to 1 minute or so. This RN was positioned in front of him to keep him from sliding on the floor. This RN was touching his hand and talking to him to rouse him. A cool cloth was placed on the back of his neck but no other position besides sitting was possible. The whole event lasted less than 5 minutes. He was talking and sipping water after rousing. He was disoriented to time and place but was quickly oriented. Client was only treated with a cool cloth behind the neck and cool water to sip on. He was able to rejoin his group within 15 minutes losing consciousness. Client had eaten breakfast before coming to clinic.
Age: 20.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MNQ
Symptoms: Pallor, Posture abnormal, Tremor
Clinical narrative: Client was given Hep A & B vaccines in left deltoid, with no concerns. Client then given HPV in right deltoid. As this RN was just starting to give the Meningococcal he stated that he was feeling lightheaded. Seconds after the 4th (mening) was given, he stated that he felt horrible and went pale, then slumped, then he became rigid and his entire body started to shake almost as if he was starting a seizure. These events lasted approximately 1-2 minutes. Help was called to the room, client slumped in his chair and lost consciousness, which lasted 30 seconds to 1 minute or so. This RN was positioned in front of him to keep him from sliding on the floor. This RN was touching his hand and talking to him to rouse him. A cool cloth was placed on the back of his neck but no other position besides sitting was possible. The whole event lasted less than 5 minutes. He was talking and sipping water after rousing. He was disoriented to time and place but was quickly oriented. Client was only treated with a cool cloth behind the neck and cool water to sip on. He was able to rejoin his group within 15 minutes losing consciousness. Client had eaten breakfast before coming to clinic.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Seizure
Clinical narrative: At 3:00 PM today, received telephone call from client's father, reporting that patient had a "seizure" about 1 hour after receiving vaccines. Described that patient felt light-headed and reported to be dizzy, then laid head down and "appeared to begin convulsing." Reports to have contacted child's pediatrician who encouraged they continue to monitor patient and notify us about the incident. Father denies any Hx/O of seizures for the patient, and admits he and child's mother are whom determined this episode a "seizure."
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: BILATERAL LOWER EXTREMITY ERYTHEMATOUS, 16.5X 12.5 CM  (RT) AND 7.0X 5.5CM (LT), RAISED, ITCHY AND WARM TO TOUCH RASH. WHICH STARTED APPROX. 3 WEEKS AFTER IMMUNIZATION.  NO DRAINAGE NOTED.
Age: 19.0
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Muscle contractions involuntary, Nausea
Clinical narrative: Sensation felt down left arm immediately and was followed by faint and nauseous feeling. Became pale and diaphoretic. Hands contracted firmly and extremities felt tingly. All symptoms arose within 30 seconds of vaccine administration and persisted for approximately 10 minutes. After 20 minutes and ~20 oz of water, all symptoms subsided.
Age: 19.0
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Pallor, Paraesthesia, Sensory disturbance
Clinical narrative: Sensation felt down left arm immediately and was followed by faint and nauseous feeling. Became pale and diaphoretic. Hands contracted firmly and extremities felt tingly. All symptoms arose within 30 seconds of vaccine administration and persisted for approximately 10 minutes. After 20 minutes and ~20 oz of water, all symptoms subsided.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Dermatitis, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: By parent report, pt developed significant swelling and redness involving right shoulder near injection site extending to right chest, upper arm, and right cheek. Went to Hospital on 8/22 for evaluation. Discharge paperwork indicates cellulitis, treated with oral CLINDAMYCIN and to return next day. Patient and mother returned to Hospital on 8/23. Discharge paperwork indicates to discontinue CLINDAMYCIN, diagnosis of dermatitis and prescription for cetirizine. Pt presented for follow-up today at her primary care provider's office, 8/24. Presents with swelling over right shoulder and erythema extending from right shoulder to upper right arm, and right chest. Mother shows pictures of site over time -- much improved, though still demonstrates significant swelling and erythema. Given improvement, plan today is to apply cold packs to site over next 2-3 days, discontinue cetirizine (was not helping to reduce itch), take one dose of diphenhydramine before bed (6.25mL).  Appt made with primary care provider for 8/28 for follow-up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling, Swelling face
Clinical narrative: By parent report, pt developed significant swelling and redness involving right shoulder near injection site extending to right chest, upper arm, and right cheek. Went to Hospital on 8/22 for evaluation. Discharge paperwork indicates cellulitis, treated with oral CLINDAMYCIN and to return next day. Patient and mother returned to Hospital on 8/23. Discharge paperwork indicates to discontinue CLINDAMYCIN, diagnosis of dermatitis and prescription for cetirizine. Pt presented for follow-up today at her primary care provider's office, 8/24. Presents with swelling over right shoulder and erythema extending from right shoulder to upper right arm, and right chest. Mother shows pictures of site over time -- much improved, though still demonstrates significant swelling and erythema. Given improvement, plan today is to apply cold packs to site over next 2-3 days, discontinue cetirizine (was not helping to reduce itch), take one dose of diphenhydramine before bed (6.25mL).  Appt made with primary care provider for 8/28 for follow-up.