chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to two patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 12-SEP-2016, the patients were vaccinated with improperly stored VARIVAX (doses and route of administrations were not reported) (Lot # L038132, expiry date: 01-OCT-2017). No concomitant therapy was reported. Temperature excursion was 11F for 3 hours. Digital Data logger was involved. There was no previous excursion. No adverse effect was 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 nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in February 2016, multiple patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L019297 expiration date 19-AUG-2017, lot # L043214 expiration date 30-AUG-2017, lot # M003659 expiration date 20-SEP-2017, Lot # M005714 expiration date 03-OCT-2017. Dose, route and anatomical location were not provided. No other concomitant medications were reported. Excursion details: The vaccine was exposed to 9 degrees F for 9 hours, as well as to 0.3 degrees F for 837 hours and as to 30 degrees F for 542 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13 months old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 04-AUG-2016 08:53 am, the patient was vaccinated with an improperly stored first dose of M-M-R II (rHA) lot # L030162 (expiration date and dose were not reported), via subcutaneous in unspecified thigh. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Patients' medical history, concurrent condition and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L038503, expiration date: 18-DEC-2017, lot # M003659, expiration date: 20-SEP-2017 or lot# L043213, expiration date: 28-AUG-2017, (Strength, dose and route of administration were not reported). Patients' concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (route and dose were unknown; lot number L040442 and expiration date 15-JAN-2017. There were no reports of adverse effects. This is one of the three reports received from the same source. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unknown patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (strength, dose, frequency and route were unknown; lot number M005714 and expiration date 03-OCT-2017). No adverse effects reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via company representative referring to a 15 year old male patient. No medical history or concurrent conditions were reported. On 22-AUG-2016 the patient was vaccinated with his first dose of GARDASIL (lot# L043214, expiration date, dose and route unspecified). Concomitant therapies included MENVEO (unspecified if it was administered in the same arm as the GARDASIL). On an unknown date in August 2016, an unspecified time after receiving the GARDASIL, the patient developed syncope. The outcome of syncope was not provided. The causality between syncope and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L008057, expiration date 01-DEC-2016, dose and route were unknown). The vaccine was stored under 0.4 degree centigrade for 18 hours. It was called because of a data logger. There was no previous temperature excursion. No adverse effect was reported. No PQC was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in January 2016, multiple patients were vaccinated with improperly stored doses of ROTATEQ lot # L027067 expiration date; 06-APR-2017, lot # L029617 expiration date 19-MAY-2017, lot # L027076 expiration date 25-MAY-2017, lot # L033545 expiration date 30-MAY-2017, lot # M004508 expiration date 29-JUN-2017, lot # M014318 expiration date 30-SEP-2017. Dose, route and anatomical location were not provided. No other concomitant medications were reported. Excursion details: The vaccine was exposed to 9 degrees F for 9 hours, as well as to 0.3 degrees F for 837 hours and as to 30 degrees F for 542 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in February 2016, multiple patients were vaccinated with improperly stored doses of PROQUAD lot # L039269 expiration date 04-APR-2017. Dose, route and anatomical location were not provided. Other suspect vaccine reported was PEDVAXHIB. No other concomitant medications were reported. Excursion details: The vaccine was exposed to -13 degrees F for a total of 184 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in January 2016, multiple patients were vaccinated with improperly stored doses of VAQTA lot # L045713 expiration date 14-JAN-2017, lot # L023936 expiration date 15-MAR-2017, lot # M009377 expiration date 17-JUN-2017, lot # L015460 expiration date 20-JUL-2017, lot # M017982 expiration date 13-SEP-2017. Dose, route and anatomical location were not provided. No other concomitant medications were reported. Excursion details: The vaccine was exposed to 9 degrees F for 9 hours, as well as to 0.3 degrees F for 837 hours and as to 30 degrees F for 542 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received 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 a nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in February 2016, multiple patients were vaccinated with improperly stored doses of VARIVAX lot # L040421 expiration date 15-OCT-2017, lot # L043624 expiration date 03-NOV-2017, Lot # 049532 expiration date 08-DEC-2017, M002063 expiration date 12-JAN-2018, M006156 expiration date 05-FEB-2018. Dose, route and anatomical location were not provided. No other concomitant medications were reported. Excursion details: The vaccine was exposed to -13 F for a total of 184 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection(strength, dose, lot number, expiration date, route of administration were not provided). It was reported that the patient was vaccinated with PNEUMOVAX 23 "every year". There were no concomitant medications reported. No adverse effects were reported and no product quality complain was involved. Additional information is not expected as the reporter did not consent for a new follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L042215, expiration date: 02-JUN-2017) (orally, dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 35.8 degrees Fahrenheit for 45 minutes. Data logger was involved. Previous excursions were at the temperature of 35 degrees Fahrenheit for 1 hour. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 26-AUG-2016 the patient was vaccinated with expired dose of ROTATEQ (dosing details were not reported) (lot # K024700, expiry date: 30-JUL-2016), The vaccine ROTATEQ did not have any previous temperature excursions. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 11-AUG-2016 the patient was vaccinated with improperly stored GARDASIL (dosing details were not reported) (lot # K026246, expiry date: 28-JAN-2016 (incorrect product storage). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 07-SEP-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (rHA, once, lot # K012473 with expiration date 26-AUG-2016, dose and route were not reported). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unknown patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency and route were unknown; lot number L029631 with expiration date 14-AUG-2017 and lot number M000442 with expiration date 31-MAR-2018). No adverse effects reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (route and dose were unknown; lot number M000996 and expiration date 07-JAN-2018). There were no reports of adverse effects. This is one of the three reports received from the same source. Additional information is not expected as there is no consent to contact the reporter.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vaccination site swelling
Clinical narrative: Small pea sized bump under the skin at the site where the vaccine was given. Right thigh is the leg that has had the reaction.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Headache, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of  headache in a 17-year-old female patient who received BEXSERO (batch number 156701, expiry date 21st AUGUST 2017). On 8th SEPTEMBER 2016, the patient received the 1st dose of BEXSERO, .5ml. On 9th SEPTEMBER 2016, 1 days after receiving BEXSERO the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved. The reporter considered the headache and general body pain to be related to BEXSERO. Additional details were provided as follows: Nurse reported that the patient experienced severe body ache and headache after receiving BEXSERO vaccine and she had also missed her school. At the end of the call, the nurse reported that "this" had happened before with other patients, but had not been reported. She did not explain what "this" was nor did nurse give details of how or which patients experienced an event. The case has been linked to case US2016132125, reported by the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K010465, expiry date: 23-MAR-2016) (route: intramuscular). The patient has not experienced an adverse effect. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: HEPA, TYP
Symptoms: Bilirubin conjugated normal, Blood bilirubin decreased
Clinical narrative: This case was reported by a physician and described the occurrence of blood bilirubin decreased in a 62-year-old male patient who received HAVRIX adult. Co-suspect products included Typhoid vaccine. Concomitant products included Nebivolol and Atorvastatin. On 1st September 2016, the patient received HAVRIX adult and Typhoid vaccine. On 7th September 2016, 6 days after receiving HAVRIX adult and Typhoid vaccine, the patient experienced blood bilirubin decreased. On an unknown date, the outcome of the blood bilirubin decreased was unknown. It was unknown if the reporter considered the blood bilirubin decreased to be related to HAVRIX adult and Typhoid vaccine. Additional details were provided as follows: The reporter was physician quality improvement professional. The age at vaccination was not reported. The patient's other medicines included Nebivolol and Atorvastatin 5 mg per day. The patient received HAVRIX adult and Typhoid vaccine in preparation for trip. On 2nd September 2016, the patient went for blood work and had a total bilirubin of 2.3 with otherwise normal liver enzymes. On the date of reporting, the total had fallen to 1.5 with a normal direct bilirubin. The patient was otherwise good in health and exercises daily. The reporter was interested to know if this could be a consequence of the vaccine and if so, what did it mean.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood test normal, Injection site pain, X-ray
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO (batch number 151401A, expiry date unknown). On an unknown date, the patient received the 2nd dose of BEXSERO 1 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site patient was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced pain in the injection area for 3 months following vaccination. The patient required several office visits, blood work and x rays. The workup resulted negative for osteomyelitis. The sales representative did not have the expiration date of the vaccine or the patient's date of birth.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 months old patient of unknown gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 01-SEP-2016, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (Concentration and dose were not reported, lot# and expiration date were unknown by the reporter),via intramuscular and a dose of PEDIARIX. The patent's concomitant medication was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23, (dose, route of administration, lot# and expiration date were not reported). Administered dose of PNEUMOVAX 23 was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on an unknown date. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrent of injection site pain in a 18-year-old female patient who received BEXSERO (batch number 151401A, expiry date unknown). On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: This case was reported by a doctor of medicine. The age at vaccination was not reported. The patient received BEXSERO on an unknown arm. The reporter stated that following the first dose of BEXSERO the patient could not lift her arm for a few weeks and had pain in the vaccinated arm that lasted for a few weeks. The events resolved and did not required doctor visits. The reporter did not have vaccination date or expiration of vaccine. I was reported that this was made in error. however, there was no duplicate case was identified and no further clarification could be obtained.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 9/13/16 at bath time mom noted (L) leg swelling and redness at immunization site. 9/14/16 customer evaluated in clinic. Tx: BENADRYL OTC PRN, cold pack to area, follow up if no improvement in 2 days.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia in a 51-year-old female patient who received RABAVERT. Concomitant products included RABAVERT. On 29th August 2016, the patient received the 2nd dose of RABAVERT. On 29th August 2016, less than a day after receiving RABAVERT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was not recovered/not resolved. It was unknown if the reporter considered the arthralgia to be related to RABAVERT. Additional details were provided as follows: On 26th August 2016, the patient received 1st dose of RABAVERT in post exposure series. After receiving 2nd dose of RABAVERT the patient developed arthralgia in the shoulders and hips. On 2nd September 2016, the patient received 3rd dose of RABAVERT. On 9th September2016, the patient received 4th dose of RABAVERT. The reporter did not have vaccine lot and expiration date.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, therapy type, route of administration, lot# and expiration date were not reported). Administered dose of RECOMBIVAX HB was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on an unknown date. Digital data logger was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Activities of daily living impaired, Headache, Impaired driving ability, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of  headache in a 17-year-old male patient who received BEXSERO (batch number 156701, expiry date 31st AUGUST 2017). On 7th SEPTEMBER 2016, the patient received the 2nd dose of BEXSERO .5 ml. On 7th SEPTEMBER 2016, less than a day after receiving BEXSERO, the patient experienced headache, driving ability disturbed and general body pain. On an unknown date, the outcome of the headache, driving ability disturbed and general body pain were not recovered/not resolved. The reporter considered the headache, driving ability disturbed and general body pain to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The patient received the vaccine in his left deltoid. Nurse reported that the patient had visited doctor for severe headache and body ache, missed his school and experienced inability to drive after receiving BEXSERO. This case was linked to case US2016132126, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 79-year-old female patient who received BOOSTRIX (batch number C295R, expiry date 8th December 2018). On 2nd September 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 8th September 2016, 6 days after receiving BOOSTRIX, the patient experienced injection site swelling, injection site itching and injection site redness. On an unknown date, the outcome of the injection site swelling, injection site itching and injection site redness were unknown. The reporter considered the injection site swelling, injection site itching and injection site redness to be probably related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in her left arm.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2016, the patient was vaccinated with a dose of PEDVAXHIB injection (dose, route and lot # not reported) that was expired "in June 2016". The reporter did not had lot # and complete expiration date of the expired vaccine administered. The reporter did not know if the patient had experienced any adverse events. No product quality complaint was involved. Additional information is not expected as the reporter did not provide consent to contact.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site burning in an unspecified number of patients who received FLUARIX TETRA. On an unknown date, the patients received FLUARIX TETRA at an unknown dose. On an unknown date, less than a month after receiving FLUARIX TETRA, the patients experienced injection site burning, injection site itching, injection site redness, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site burning, injection site itching, injection site redness, injection site swelling and injection site warmth were unknown. The reporter considered the injection site burning, injection site itching, injection site redness, injection site swelling and injection site warmth to be related to FLUARIX TETRA. Additional details were provided as follows: The age at vaccination for the patients was not reported. The reporter had noticed high percentage of patients who had received the FLUARIX QUADRIVALENT vaccine via the prefilled syringes for the 2016-2017 season and had experienced local injection site reactions including itching, burning, redness, swelling and hot feeling. Other patients had experienced only burning as the vaccine was being administered (refer case US2016GSK136583). The field representative was unable to provide any further details at the time of the call. The field representative indicated that this practice was a new user of the FLUARIX QUADRIVALENT product and had only been using the product for approximately two weeks before the time of reporting. He was also going to contact Medical Information.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Patient presented with open blister on left arm on 6/18/16 at 5:56 pm. Patient stated that he had thought there was a blister at the injection site and that it ripped when he scratched it. The skin did not look infected. Keep clean and apply ATB ointment. Told patient we would follow up.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Throat tightness, Wheezing
Clinical narrative: Wheezing - shortness of breath- Reported he felt his throat was thickening. Reported local reaction in past about 7 years ago. Epinephrine IM5cc SQ BENADRYL 50 mg P.O. Symptoms subsided after 15 min post epinephrine.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of injection became red and hard.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness from injection site to elbow on (R) arm reported by mother. Resolved next day. No other symptoms.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis
Clinical narrative: Myocarditis 11 days after vaccination.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Decreased appetite, Dysgeusia, Fatigue, Headache
Clinical narrative: Gave AFLURIA first in one arm, followed by ZOSTAVAX in other. Immediately upon finishing admin for shingles, Pt reported sharp, stinging, metallic taste and to be watching the room spin. Then a severe headache set in. For next 3 days severe headache, body ache, fever and chills. Unable to eat  d/t rash, stinging and metallic taste in mouth. Started Prednisone pack - helped resolve but exhausted.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pyrexia, Vertigo
Clinical narrative: Gave AFLURIA first in one arm, followed by ZOSTAVAX in other. Immediately upon finishing admin for shingles, Pt reported sharp, stinging, metallic taste and to be watching the room spin. Then a severe headache set in. For next 3 days severe headache, body ache, fever and chills. Unable to eat  d/t rash, stinging and metallic taste in mouth. Started Prednisone pack - helped resolve but exhausted.
Age: 7.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Erythema multiforme, Generalised erythema, Oral mucosal erythema, Rash generalised, Skin plaque
Clinical narrative: Erythema multiform minor-rash present on body surface and some erythema on soft palate. (Raised erythematous plaques all over body, face, palms of hands).
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Henoch-Schonlein purpura, Rash
Clinical narrative: Patient started with rash 4 hours after administ. Pt went to E.R. and was diagnosed with Henoch-Schonlein Pupura.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site swelling, Pyrexia
Clinical narrative: Swelling of the right arm at injection site. Could not move arm x few days, and fever.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red raised area on upper arm, burning 3 itching.
Age: 53.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash
Clinical narrative: Rash developed on inner arm from elbow down 120 hrs post injection. Administered to upper left arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Infection, Injection site inflammation
Clinical narrative: Patient has inflammation at the injection sites. Upper arm left to elbow. There was a red spot on the arm on the other side of site.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. In approximately June 2016 (reported  as "27-JUN-2016 or 28-JUN-2016"), the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M004116, expiration date 12-OCT-2017, dosing details and route were not provided). The vaccines were exposed under 28 Fahrenheit degree (F) for 3 hours and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality issue was involved. Follow up information has been received from the licensed practical nurse and a office manager on 01-SEP-2016 referring to a female patient of unknown age. The patient received a revaccination with GARDASIL 9 on 28-JUN-2016. It was unknown which shot in the series these revaccinations was. This is one of several reports received from the same reporter. Additional information has been requested. General, patient and narrative are updated.
Age: 56.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Chills, Influenza like illness, Pain, Pyrexia, Rash erythematous
Clinical narrative: Vaccines. Flu like symptoms, 101 fever, body aches. Chills. Started 7 pm 9/19. 9/19 at 12:00 got shots. 9/21 - Urticarial red rash.
Age: 56.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Urticaria
Clinical narrative: Vaccines. Flu like symptoms, 101 fever, body aches. Chills. Started 7 pm 9/19. 9/19 at 12:00 got shots. 9/21 - Urticarial red rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: (R) thigh rash approximately 10 x 7 cm with induration, tender to palpation, swelling. Rash expanding from origin of vaccination out.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Pt. called grocery store pharmacy after clinic, pharmacy closed. Arm where rec'd FLUZONE QUAD 16/17 swelled in egg-shape size reaction. Pt. used ice pk and ZYRTEC as soon as reaction occurred. Pt. slept whole next day.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Contusion, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Hive-itching L leg-7-14-16; severe headache-7-14-16 nausea, stomach discomfort-3wks; vomiting on 7-18-16; appetite change; Extreme Lethargy and sleepiness for 3 weeks; continued headache and fatigue.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Vomiting
Clinical narrative: Hive-itching L leg-7-14-16; severe headache-7-14-16 nausea, stomach discomfort-3wks; vomiting on 7-18-16; appetite change; Extreme Lethargy and sleepiness for 3 weeks; continued headache and fatigue.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal discomfort, Appetite disorder, Fatigue, Headache, Lethargy
Clinical narrative: Hive-itching L leg-7-14-16; severe headache-7-14-16 nausea, stomach discomfort-3wks; vomiting on 7-18-16; appetite change; Extreme Lethargy and sleepiness for 3 weeks; continued headache and fatigue.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Pruritus, Somnolence, Urticaria, Vomiting
Clinical narrative: Hive-itching L leg-7-14-16; severe headache-7-14-16 nausea, stomach discomfort-3wks; vomiting on 7-18-16; appetite change; Extreme Lethargy and sleepiness for 3 weeks; continued headache and fatigue.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Tremor
Clinical narrative: Took 2 acetaminophen that day (4-5 hours apart). Severe chills started, severe shaking upper body and jaw. Got into bed and got warm and chills subsided. Nauseous and diarrhea.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Diarrhoea, Nausea, Tremor
Clinical narrative: Took 2 acetaminophen that day (4-5 hours apart). Severe chills started, severe shaking upper body and jaw. Got into bed and got warm and chills subsided. Nauseous and diarrhea.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Rash, Wheezing
Clinical narrative: This spontaneous report was received from a nurse and refers to 13 year old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine and walnuts/pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Oral mucosal eruption, Rash, Testicular pain, Testicular swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to 13 year old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine and walnuts/pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Wheezing
Clinical narrative: This spontaneous report was received from a nurse and refers to 13 year old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine and walnuts/pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Oral mucosal eruption, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a nurse and refers to 13 year old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine and walnuts/pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to 13 year old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine and walnuts/pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient reported that the vaccine site was achy "as usual" (she receives flu shots yearly), then started to feel itchy and appeared red and mildly swollen from shoulder to elbow about 2 days after the shot. The redness/ swelling/ itch persisted until the day this issue was reported to pharmacy (9/18/16) "unchanged", according to patient.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Arm was tender, warm, red for 2 weeks. No treatment.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Mild hives and generalized itchiness developed, especially on the side of the body that the vaccine was administered. Continued throughout the following 12 hours (which is when I am filing this report). No treatment measures have been taken.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Painful to touch and warmth at site, induration, redness, itching; ibuprofen for pain.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Very hard coughing and sore throat, very hard pain in throat that drink and eat hardly. I went doctor twice. First I went to hospital 09/16/2016 for doctor visiting and emergency doctor then I went to  urgent care center in 09/19/2016 medications by doctors: biaxin benzonanate ibuprofen fluticasone brophereniramine cepacol sore throate Q-tussin AF .
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Electroencephalogram, Epistaxis
Clinical narrative: Severe nosebleed, First Seizure 05/13/2016; 2nd Seizure 08/19/2016; 3rd Seizure 05/20/2016.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Severe nosebleed, First Seizure 05/13/2016; 2nd Seizure 08/19/2016; 3rd Seizure 05/20/2016.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Flushing, Injection site induration, Paraesthesia, Skin tightness
Clinical narrative: Flush face and tingling of scalp for 3 to 4 hours starting at 11:50 AM. Tightness from elbow to behind right ear for 2 days. Hardness at injection site for 4 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction at this time. Patient was given MMRV and Varicella Vaccine at same visit. Additional person responsible, MA.
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Mom reports child developed severe rash a week after vaccination.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, some unspecified patients among these multiple patients were vaccinated with improperly stored M-M-R II (lot # L041457 with expiration date 22-OCT-2017, or lot # L009214 with expiration date 17-MAR-2017, or lot # L030162 with expiration date 11-AUG-2017, dose and route not reported). On 21-JUN-2016 or 23-JUN-2016 or 01-AUG-2016, other unspecified patients were vaccinated with the same improperly stored vaccine (lot # L009545 with expiration date 19-MAR-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old female patient with drug allergy to penicillin. There was no pertinent medical history. On 25-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L046897, expiration date 23-FEB-2017, subcutaneous). Concomitant therapy included multiple unspecified medications. The patient had "injection site pain and joint pain in the left knee for the past week". There were no diagnostic lab studies performed. The outcome of injection site pain and arthralgia was reported as not resolved. Additional information has been requested.