chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Deafness, Dizziness, Loss of consciousness, Muscle twitching
Clinical narrative: My son reported feeling dizzy and could not hear about 10 minutes after Gardasil vaccine.  He then lost consciousness for about 60 seconds.  Woke up and lost consciousness again with twitching in arms and legs.  Smell salts were used to help bring him to. I've brought him home with periods of dizziness but no loss of consciousness.   I feel its important to report this because its direct correlation to the vaccine is indisputable. He has never had any reaction from any shots or blood draw.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: Area near vaccine injection sight became inflamed, warm to touch and itching.  Redness was about the size of palm of hand (per patient).  Patient returned to pharmacy on 6/27/16 with picture of area.  Area had cleared by late am on 6/27/16.
Age: 5.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong vaccine administered, no reaction.
Age: 10.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swelling and redness around vaccine site.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Uncomfortable, hot, red rash developed around the injection site that has progressively gotten larger.
Age: 1.01
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Erythema, Injection site rash, Injection site urticaria, Papule, Polymerase chain reaction
Clinical narrative: Rash started on left leg with one small spot that may have been a hive.  Rash has progressed to multiple spots of little bumps, bumps are linear. Traveling along the diaper, and developed a new patch this am along his back.   Mom tried Zyrtec and hydorcortisone with mininal response.  + itching. No travel, no daycare.  Did go to beach last week, mom denies any poison oak exposure. H/O food allergy to oat and peanut.    No fevers, acting well except for the itching." Photos show grouped erythematous papules that appear close to possible vesicuation over and L3-L5 dermatomal distribution.
Age: 1.01
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Pruritus, Rash, Varicella virus test
Clinical narrative: Rash started on left leg with one small spot that may have been a hive.  Rash has progressed to multiple spots of little bumps, bumps are linear. Traveling along the diaper, and developed a new patch this am along his back.   Mom tried Zyrtec and hydorcortisone with mininal response.  + itching. No travel, no daycare.  Did go to beach last week, mom denies any poison oak exposure. H/O food allergy to oat and peanut.    No fevers, acting well except for the itching." Photos show grouped erythematous papules that appear close to possible vesicuation over and L3-L5 dermatomal distribution.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Headache, Nausea, Vomiting
Clinical narrative: Vomiting, nausea, headache, stomach ache; tried Pepcid and Pepto Bismol to no effect; went to ER and was given antiemetic (nausea) and donnatal (pain) to no effect; given 1 liter IV, which helped a lot. Symptoms reappeared after each subsequent dose.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Erythema, Skin warm, Swelling
Clinical narrative: BURNING IN THE AREA, SWOLLEN, RED AND WARM TO TOUCH.  SWELLING SPREAD TO SIZE OF A HAND. LASTED ABOUT 3 WEEKS.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came to pharmacy the day after vaccination with redness about 2 inches and swelling at the injection site.
Age: 1.52
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Eye swelling, Pruritus generalised, Rash erythematous, Rash generalised, Skin warm
Clinical narrative: My son woke up with couple marks on temple an thighs an about ten days later 6-26-2016 we noticed full body rash head to toe covered red warm bumps itching everywhere , then woke up 06-27-2016 eyes swollen we called doctor scheduled appointment they weren't to concerned said it's normal after varicella vaccine sent us home with Zyrtec.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin infection, Skin warm
Clinical narrative: Started to see arm turning red rash, rash spreading down arm, warm.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Chest discomfort, Computerised tomogram, Injected limb mobility decreased
Clinical narrative: May 3, 2016 when I first went to Dr for a physical and was given a pneumonia shot on this visit in the muscle left upper arm. On May 4 my upper left arm was very painful, could not lift my arm above my head. On May 5, 2016 face swelling, chest discomfort May 19 right leg swelling.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Peripheral swelling, Swelling face, Ultrasound scan
Clinical narrative: May 3, 2016 when I first went to Dr for a physical and was given a pneumonia shot on this visit in the muscle left upper arm. On May 4 my upper left arm was very painful, could not lift my arm above my head. On May 5, 2016 face swelling, chest discomfort May 19 right leg swelling.
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This solicited report has been received from a patient's mother, as part of a marketing research program, referring to a young patient (age and gender were unspecified). The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route were not reported). On an unknown date, the patient experienced chronic headaches. The reporter stated that "it is not as safe as other vaccines". The outcome of the chronic headaches was unknown. Additional information is not expected at the reporter did not consent for further follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical  nurse referring to an unspecified number of patients. On unspecified dates an the patients were vaccinated with VARIVAX (lot # L021215, expiration date 10-JUN-2017, dose and route were not reported) which was improperly stored. The vaccine has been stored under temperature of 40 Fahrenheit temperature for 2.5 hours. No adverse effects were reported. This is one of several reports of the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On an unspecified date, unspecified number of PEDVAXHIB vaccines were exposed to 58 degrees F for 94 hours. After that, on unspecified dates, the patients were vaccinated with lot number: L012835 (expiration date: 11-MAR-2018) (dose and route were not provided). No adverse events were reported. The medical assistant stated that the vaccines were not previous exposed to temperature excursion. Information was recorded from a data logger. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 23-JUN-2016 the patient was inadvertently administered an expired dose of M-M-R II (lot # K008625, expiration date 16-JUN-2016, dose and route not specified). No adverse effect reported. Additional information is not expected because there was no consent for follow up.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a nurse practitioner via the company representative regarding a 17 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date approximately in June 2013, the patient was vaccinated with GARDASIL injection, dose 1, intramuscular (strength, lot # and expiration date unknown). On an unknown date approximately in June 2013, the patient experienced anaphylactic reaction immediately after receiving the first dose of GARDASIL. No product quality issue was involved. The outcome of anaphylactic reaction was reported as recovered on an unknown date. Causality assessment was not provided by the reporter. Upon internal review, anaphylactic reaction was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUN-2016, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX, that had expired on 03-JUN-2016 (lot # K007977, subcutaneous). There was no adverse effects reported. Additional information is not expected because there was no consent to contact medical assistant.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L035286, expiration date 15-DEC-2016; dose and route unspecified), which were previously exposed to temperature excursion 9.6 Celsius degree (C) for 1 hour and 45 minutes because of a data logger. The currently temperature frame was reported as -14.3 C for 1 hour and 34 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # L009210 expiration date 17-SEP-2016; dose and route unspecified), which were previously exposed to temperature excursion of 9.6 Celsius degree (C) for 1 hour and 45 minutes because of a data logger. The currently temperature frame was reported as -14.3 (C) for 1 hour and 34 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The patients were administered improperly stored doses of GARDASIL 9 (Lot L020015, expiration date 16-AUG-2017, dose and route were unknown) on the following dates: 19-APR-2016 (1 dose), 16-MAY-2016 (1 dose), 31-MAY-2016 (1 dose), and 01-JUN-2016 (1 dose). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The patients were administered improperly stored doses of oral ROTATEQ (Lot # L035637, expiration date 09-JUN-2017, dose was unknown) orally on the following dates: 12-APR-2016 (1 dose), 14-APR-2016 (1 dose), 15-APR-2016 (2 doses), 18-APR-2016 (1 dose), 19-APR-2016 (1 dose), 22-APR-2016 (1 dose), 02-MAY-2016 (1 dose), 10-MAY-2016 (1 dose), 18-MAY-2016 (1 dose), 23-MAY-2016 (1 dose), 25-MAY-2016 (1 dose), 31-MAY-2016 (1 dose), and 03-JUN-2016 (2 doses). No adverse effect was 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: Information has been received from a licensed practical nurse concerning unspecified number of patients of unknown age or gender. There was no information about concurrent condition, medical history or concomitant therapy. On unspecified dates, the patients received doses of improperly stored VARIVAX (dose and route not provided, lot # included: L000455 with expire date 06-JAN-2017 and L017142 with expire date 13-MAY-2017). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions or concomitant therapies were provided. On unspecified dates improperly stored vaccines were administered to unspecified number of patients (doses, routes, and indications were not reported). No symptoms were reported. One dose of VAQTA lot # L015460, expiry date 20-JUL-2017 was administered, one dose of RECOMBIVAX HB lot #L027733 expiry date 13-SEP-2017 or lot # L040458 expiry date 04-FEB-2018 was administered and five doses of ROTATEQ were administered lot # L033549 expiry date 05-JUN-2017, lot # L027726 expiry date 10-MAY-2017, lot #L033545 expiry date 30-MAY-2017 were administered. The reporting nurse was not sure which lot numbers were administered but the lot numbers listed above were the ones possibly involved. It was reported that the vaccines were exposed to temperatures of 46.9 Fahrenheit degrees for 15 minutes and 34.9 Fahrenheit degrees for 2 hours. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 23-JUN-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot # K018176, expiry date: 10-JAN-2016 (dose, vaccination site and route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a GlaxoSmithKline representative on behalf of a healthcare professional. The representative received notification via email, that 2 children were experienced adverse reaction after receiving BEXSERO vaccine. The representative was only able to provide the phone number for the healthcare professional and a follow-up call was placed and voice message was left, requesting a call back to provide additional information. No further information was provided. This case has been linked with US2016087331, reported by the same reporter.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site induration in a 16-year-old male patient who received BEXSERO. In June 2016, the patient received BEXSERO. In June 2016, less than a week after receiving BEXSERO, the patient experienced injection site induration, injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site warmth and injection site pain were unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site warmth and injection site pain to be related to BEXSERO. Additional details were provided as follows: This case was not previously reported to anyone. The patient received  a dose of BEXSERO vaccine and developed a large area of induration between vaccination date and the date of reporting, approximately 3 to 6 inches. The redness surrounding the induration was a bit larger. The injection site had a hot feeling and was painful. The reported vaccination date was unclear: it could be the 15th June 2016 or 16th June 2016. The Medical Science Liaison (MSL) received the adverse events in the form of an email so, he did not have address of the reporter.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt presents to clinic with c/o redness and swelling in lt upper arm, reports mild tenderness, rates 2/10. Pt had a PREVNAR 13 on 3/22. Reports that he just noticed the redness and tenderness yesterday. Red area noted approx. 3" diameter on lt upper arm. No drainage or open area.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown date, the patient was vaccinated with the improperly stored dose of PROQUAD lot #: L024125, expiration date on 30-DEC-2016 (route, dose, and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 22.1 degrees Celsius for 16 hours. Data logger was involved. There was no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Skin discomfort, Urticaria
Clinical narrative: 2 16 year old twin boys, received TRUMENBA shot. 8 hours later they ran a 102.0 fever lasting 24 hours. They also said the skin on their back, head and arms felt raw but looked normal. They broke out in hives 12 hours after the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple unspecified patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L037790, expiry date: 30-DEC-2016, route of administration was not reported). Concomitant therapy was not reported. Reported temperature excursion was 10F for 48 hours. Data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Chest discomfort, Generalised erythema, Pruritus generalised, Swollen tongue
Clinical narrative: Information has been received from the published literature article referring to a 62 year old female patient with allergy to penicillin class medications. On an unknown date (at work same day), the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (dose, route and lot# were unknown). After vaccination (onset not documented), the patient experienced generalized pruritus, erythema, tongue swelling and chest tightness. The initial evaluation was performed in a clinic and the physician's assistant provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with parenteral antihistamine and oral H2-blocker. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Dizziness, Nausea, Wheezing
Clinical narrative: Information has been received from the published literature article referring to a 64 year old female patient with asthma and allergy to other unspecified medications. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route and lot# were unknown). After vaccination, the patient experienced wheeze (bilateral), dizziness and nausea. The initial evaluation was performed in a clinic and the internist doctor provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with bronchodilators. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
Sex: U
Vaccine: MENB, UNK
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a GlaxoSmithKline representative on behalf of a healthcare professional. The representative received notification via email, that 2 children were experienced adverse reactions after receiving BEXSERO vaccine. The representative was only able to provide the phone number for the healthcare professional and a follow-up call was placed and voice message was left, requesting a call back to provide additional information. No further information was provided. This case has been linked with US2016GSK090355, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L002422, expiry date: 23-APR-2016, route of administration was not reported). Concomitant therapy was not reported. No adverse effect was reported. It was also reported that, expired dose of ZOSTAVAX was supported as per the post expiry memo. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Oedema, Pruritus, Urticaria
Clinical narrative: Urticaria pruritus and edema, erythema, itching. Acetaminophen 2 tab once, ceftriaxone 1 gm once, methylprednisolone 80 mg once.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a two patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-MAY-2016, the patients were vaccinated with an expired dose of VAQTA lot #: L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 04-MAY-2016, the patient was vaccinated with an expired dose of VAQTA lot #: L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-MAY-2016, the patient was vaccinated with an expired dose of VAQTA lot #: L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 19-MAY-2016, the patient was vaccinated with an expired dose of VAQTA lot # L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13, TTOX
Symptoms: Erythema, Erythema multiforme, Peripheral swelling
Clinical narrative: Erythema multiform and arm swelling, erythema.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-MAY-2016, the patient was vaccinated with an expired dose of VAQTA lot# L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On an unspecified date in March 2016, unspecified number of VARIVAX vaccines were exposed to a temperatures ranged from -1.0 degrees C to -14.8 degree C. After that, on unspecified dates in 2016, the patients were vaccinated with lot numbers: L031066 (expiration date: 18-AUG-2017), L020000 (expiration date 02-JUN-2017), and M000760 (expiration date: 06-JAN-2018. No adverse events were reported. The licensed practical nurse, stated that the vaccines were not previous exposed to temperature excursion. Information was recorded from a data logger. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On an unspecified date unspecified number of M-M-R II vaccines were exposed to 58 F for 94 hours. After that, on unspecified dates, the patients were vaccinated with lot numbers: L019989 (expiration date: 01-JUN-2017), and K021151 (expiration date 02-NOV-2016). No adverse events were reported. The medical assistant stated that the vaccines were not previous exposed to temperature excursion. Information was recorded from a data logger. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker/certified medical assistant and refers to 4 patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L050908, expiry date: 14-JUN-2017, route of vaccination was not reported). Concomitant therapy was not reported. Reported temperature excursion was -11 degree of Celsius for 15 hours. Data logger was involved. There was no previous temperature excursion. No adverse symptom was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified patients of unknown age or gender. There was no information about concurrent condition, medical history or concomitant therapy. On an unknown dates from 2008 to present, the patients received approximately 230 doses of improperly stored VARIVAX injection (lot#, dose and route not provided). It was unknown what the temperature and time frame details that the vaccines were exposed to. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. The patient received GARDASIL intramuscularly (dose, lot # and expiration date not reported) or GARDASIL 9 intramuscularly (dose, lot # and expiration date not reported) (it was unspecified which vaccine) outside of the dosing schedule. In August 2014, the patient received the first dose. The second dose was administered to the patient in April 2015 and the third dose in May 2105. No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a 14 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 02-JUN-2016, the first dose in the series of GARDASIL 9 was administered to the patient (dose and route were not reported). On 14-JUN-2016, the patient was ordered to be administered with VARIVAX and was inadvertently vaccinated with her second dose of GARDASIL 9 (lot # M007728, expired date 21-MAR-2018, once) intramuscularly. No adverse event was reported. The patient did not seek medical attention. No treatment was given to the patient. It was also reported that vaccination with GARDASIL 9 would be continued. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to two unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The patients were administered improperly stored doses of GARDASIL (Lot # K007264, expiration date 02-MAR-2017, dose and route were unknown) on 06-JUN-2016. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown date, the patient was vaccinated with the improperly stored dose of PROQUAD lot #: L024125, expiration date on 30-DEC-2016 (route, dose number and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 22.1 degrees Celsius for 16 hours. Data logger was involved. There was no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash erythematous, Urticaria
Clinical narrative: 2 or 3 days after vaccination noticed itching. Noticed patches of red on upper thigh and arms and trunk and small red bumps like whelps. He put A&D ointment.
Age: 17.0
Sex: F
Vaccine: MENB, HEPA, MENB
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Woke 06/21/2016 with pain at injection site (L) deltoid. Severe neck pain at the base of neck. Headache. No fever. Stiffness of neck decreased on 6/26/16.
Age: 17.0
Sex: F
Vaccine: MENB, HEPA, MENB
Symptoms: Neck pain
Clinical narrative: Woke 06/21/2016 with pain at injection site (L) deltoid. Severe neck pain at the base of neck. Headache. No fever. Stiffness of neck decreased on 6/26/16.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: KINRIX was used in 4 mo old rather than INFANRIX no adverse event was reported.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: High fever 24 hours 103.6 (per mom).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site papule
Clinical narrative: (L) deltoid area with small central eryth papule with very mild erythema and induration approx. 1.5 cm surrounding.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Presyncope
Clinical narrative: Arm pain is primary symptom. Vasovagal syncope the following morning due to continued pain.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: After administration of TDaP and MENACTRA, patient passed out. Was assessed by provider - no injuries. Was monitored 20-25 minutes before leaving. Of note- pt was very nervous prior to administrations.
Age: 1.32
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given KINRIX instead of PEDIARIX. Pt was up to date on Hep B vaccinations. Pt had no adverse effects.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Rash vesicular, Urticaria
Clinical narrative: Broke out in hives the next day. Family physician determined it was a chicken pox like reaction. Joints hurt.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Received HPV9 on 6/13/16. States it hurts to move left arm. Indicates area at deltoid. Mom has been using ice packs daily.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site papule, Injection site swelling, Local reaction
Clinical narrative: Local reaction - erythematous papules on both thighs at site of injection slightly raised; occurred within 24 hr of vaccines.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site hypoaesthesia, Injection site induration, Injection site pain
Clinical narrative: On 6/20/16 noted soreness and numbness to left deltoid muscle, continues through today. Patient came into clinic to have this nurse see her left deltoid muscle after her mother called this morning. Left deltoid muscle, area of hardness noted, and sore to touch, but patient said, not as bad as it has been, no inflammation noted at site. No treatment given.
Age: 1.26
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Erythema, Papule, Skin lesion
Clinical narrative: Trunk: approximately 10 lesions on anterior chest/abdomen: small 2-4mm red papules with tiny white centers, 2 on back; Extremities: one on each calf, one on medial buttock, 1-2 on each arm. Rash began on arms at daycare earlier today 6/23 followed by rapid appearance of the truncal lesions. Otherwise well, no oral or genital lesions, afebrile.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Redness; itchiness; fever; chills; arm pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope - cold compress was applied.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Joint range of motion decreased
Clinical narrative: Received TDaP 6/7/2016. Discomfort began that day. 6/16/16 called nurse recommended IBU or/and go to walk in clinic. Decided to try meds. Did not improve under treatment. Dec arm range of motion not recovered.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Blood lactic acid, Full blood count, Hypoaesthesia, Injection site erythema
Clinical narrative: 11 yr. vaccines given 6/14/16 at well exam. C/o redness, swelling to vaccine site (left arm) pain to site on 6/24/16. C/o pain to site w/cont. redness, swelling on 6/25/16 and (R) shin pain, (R) wrist pain, and numbness to (R) top on the foot. Seen at hospital ER 6/25/16. F/u here visit 6/27/16. Poss bug bite on top of (R) ft. Poss. puncture site noted on (R) ft.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Metabolic function test, Pain in extremity, Ultrasound joint, Urine analysis
Clinical narrative: 11 yr. vaccines given 6/14/16 at well exam. C/o redness, swelling to vaccine site (left arm) pain to site on 6/24/16. C/o pain to site w/cont. redness, swelling on 6/25/16 and (R) shin pain, (R) wrist pain, and numbness to (R) top on the foot. Seen at hospital ER 6/25/16. F/u here visit 6/27/16. Poss bug bite on top of (R) ft. Poss. puncture site noted on (R) ft.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vaccination site swelling
Clinical narrative: 11 yr. vaccines given 6/14/16 at well exam. C/o redness, swelling to vaccine site (left arm) pain to site on 6/24/16. C/o pain to site w/cont. redness, swelling on 6/25/16 and (R) shin pain, (R) wrist pain, and numbness to (R) top on the foot. Seen at hospital ER 6/25/16. F/u here visit 6/27/16. Poss bug bite on top of (R) ft. Poss. puncture site noted on (R) ft.
Sex: U
Vaccine: HPVX
Symptoms: Breast haemorrhage, Mastitis
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of unidentified Merck human papillomavirus (HPV) vaccine (dose, route of administration, lot# and expiration date were not reported). The reporter did not know if it was GARDASIL or GARDASIL 9. On an unknown date after the vaccination, the patient developed a breast duct infection with bleeding. The outcome of the adverse events and the relatedness between them and unidentified Merck human papillomavirus (HPV) vaccine were not reported. Upon internal review, the events of breast duct infection and bleeding were considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. In June 2016 (reported as "this past week"), the patient was vaccinated with an unknown dose of PNEUMOVAX 23 (site and route of administration, lot # and expiry date were not reported). Concomitant medications were not reported. On 24-JUN-2016, the patient sought medical attention at an Urgent Care and he was diagnosed with cellulitis. It was unknown if the treatment was given for the event. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, Herpes zoster, Impaired work ability
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified day in February 2015 and on an unspecified day in April 2015, the patient was vaccinated with the first and the second dose of VARIVAX (lot number, expiration date, dose and frequency were not reported) subcutaneously, respectively. On an unspecified day in May 2016, the patient was inadvertently vaccinated with a third dose of VARIVAX (lot number, expiration date, dose and frequency were not reported) subcutaneously. Three days later, on an unknown day in 2016, the patient developed shingles. None laboratory tests were performed. At the time of the report, the patient did not recover from the shingles. The relatedness between shingles and VARIVAX was not reported. The reporter considered shingles as a significant disability as the patient stated that she could not return to work until the shingles had resolved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml one time, subcutaneous; lot# and dose# unknown). On an unknown date following the vaccination, the patient experienced ophthalmic zoster. The patient had sought unspecified medical attention. The outcome of the event was unknown. Upon internal review, the event ophthalmic zoster was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Head injury, Malaise, Moaning, Seizure like phenomena, Syncope
Clinical narrative: Within 10 minutes after receiving MENACTRA, my daughter said I don't feel well, fainted, hit head on wall, began having seizure-like jerking, shaking and moaning and was unresponsive for a few minutes.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Within 10 minutes after receiving MENACTRA, my daughter said I don't feel well, fainted, hit head on wall, began having seizure-like jerking, shaking and moaning and was unresponsive for a few minutes.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approx 5 fingers below injection site an indurated, reddened and warm to touch area approx 5 fingers wide appeared.  The area is very painful, swollen, and reddened with a definite hardened edge.  I have not been able to lay on this arm or have anyone else touch it due the pain.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED OUT AFTER GETTING THE SECOND VACCINE. PATIENT WAS SUPPORTED BY NURSE AND DAD. WHEN HE CAME TO HE WAS LAID ON A COT AND ICE PACKS WERE APPLIED TO HIS NECK AND JUICE WAS GIVEN AT THAT TIME. AFTER 20 MINUTES OF MONITORING PATIENT STATED HE WAS FEELING MUCH BETTER AND WALKED TO CAR WITH DAD.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cough, Death, Malaise, Pneumonia
Clinical narrative: Pt was seen in the office for a AWV on 6-20-16 and was fine. He was given a pneumonia vaccine that day. Wife called the office 6-24-16 stating he started getting sick on 6-22-16 with chills and a cough. Pt became sicker and went to ER on the 26th and died on the 27th. Patient is a 82 y.o. male who presents for a "Annual Wellness" exam. Current concerns included AWV. Pt still sees cardio once a year for HTN, HLD, aortic stenosis and hyperhomocystenemia. Sees neuro once a year for stroke. Chronic constipation - stable. Takes AMITIZA prn if needed.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia bacterial
Clinical narrative: Pt was seen in the office for a AWV on 6-20-16 and was fine. He was given a pneumonia vaccine that day. Wife called the office 6-24-16 stating he started getting sick on 6-22-16 with chills and a cough. Pt became sicker and went to ER on the 26th and died on the 27th. Patient is a 82 y.o. male who presents for a "Annual Wellness" exam. Current concerns included AWV. Pt still sees cardio once a year for HTN, HLD, aortic stenosis and hyperhomocystenemia. Sees neuro once a year for stroke. Chronic constipation - stable. Takes AMITIZA prn if needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Urticaria, Vomiting
Clinical narrative: Vomiting immediately after vaccine x 2, then again 15 min later then 30 min after vaccine, developed urticaria of extremities and face.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Asthma, Bronchitis, Cardiac monitoring, Chest X-ray
Clinical narrative: Started swelling with mild swelling, by 6/22 am some rash had started on my arm and by 6-23 PM it had spread all of the way down to my wrist and had started on my other arm.  I had started having some mild wheezing and coughing issues.  I took Benadryl and applied Ice packs and went to the icc on 6-24 they gave me steroid shots and antibiotics and told me to continue with and inhaler and Benadryl and ice packs and follow up with a doctor on Monday. By Sunday night I could barely breathe and was un able to get out of bed. I went to the hospital on 6-27 with acute asthma and acute bronchitis.  Had 3 breathing treatments, steroid iv, Percocet for the pain in my chest and ribs from coughing so hard, cough meds, and they sent me home with prednisone, cough meds and doxycycline. I saw my doctor today 6-28-16 for a follow up and she said it was an anaphylactic reaction to the shot. I still have bruising all around my arm from the extreme swelling, itching, and am having trouble breathing.