chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be 1) 26-MAY-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this male (age unknown) were reported to be 1) 19-NOV-2014 and  2) 08-AUG-2014. [Dates as reported. Await clarification of the year for these vaccines]. It was also documented for this patient (Also finish Hep A series). No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 10-AUG-2012 and 2) 20-AUG-2013. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be  1) 22-JUL-2016.  [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be 1) 28-JUL-2016. [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be 1) 09-AUG-2016. [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 18-AUG-2015 and 2) 23-DEC-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 19-NOV-2012 and 2) 14-AUG-2013. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be 1) 11-AUG-2016. [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of currently 1 year old and unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of both PROQUAD with lot number M033210 and expiration date of 09-JAN-2018, subcutaneously (strength, dose and anatomical location were unknown) and a dose of VARIVAX with lot number M024683 and expiration date of 18-MAY-2018, subcutaneously (strength, dose and anatomical location were unknown) at the same office visit for prophylaxis. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 21 January 2017. This case involves an 81-year-old male patient who was vaccinated with a dose of FLU SHOT (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history was reported as the patient got sick after had flu shot in 1992 and didn't take it again until 1998 also reported that the patient got sick again and took shot for pneumonia last winter because he has had pneumonia. Concomitant medications were not reported. On 21 January 2017, unspecified time following the vaccination, the patient got sick. Laboratory investigations was not reported. The patient had not received any corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL, DTAP, HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Patient presented skin rash about 20 minutes after administration.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Itching and redness on the front part of the neck.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Head discomfort, Lacrimation increased, Mouth breathing
Clinical narrative: Started with sneezing then progressed to nasal congestion alternate with runny nose, watery eyes, mouth breathing and chest tightness with occasional non-productive cough with pressure on head which she attributes possibly nasal congestion, denies fever, SOB.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Started with sneezing then progressed to nasal congestion alternate with runny nose, watery eyes, mouth breathing and chest tightness with occasional non-productive cough with pressure on head which she attributes possibly nasal congestion, denies fever, SOB.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Blood test normal, Chills, Decreased appetite, Diarrhoea
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 03-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU) refrigerated vial (injection) (route of administration, lot # and expiration date were not reported) for prevention of shingles. On 03-JAN-2017, the patient experienced redness and pain in the arm with an unspecified rash. On 04-JAN-2017, the patient had a headache and left lower quadrant abdominal pain. On 06-JAN-2017 through 09-JAN-2017, the patient had diarrhea, fever and chills. As of the date of this report the diarrhea had gone away, but the patient "still had symptoms coming to the middle through her rectum" and a decreased appetite developed on an unknown date in January 2017. On 10-JAN-2017, the patient sought medical attention and visited nurse practitioner office complaining about her symptoms. The nurse practitioner ordered unspecified blood work and a urinalysis. Both came back normal. The nurse practitioner recommended a bland diet and over the counter PEPCID or omeprazole. As of 18-JAN-2017, the the symptoms were improving but not gone except of diarrhea which was resolved on an unknown date in January 2017. It was reported, if the symptoms remain unresolved, the nurse practitioner would order a computer tomography (CT) scan. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 03-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU) refrigerated vial (injection) (route of administration, lot # and expiration date were not reported) for prevention of shingles. On 03-JAN-2017, the patient experienced redness and pain in the arm with an unspecified rash. On 04-JAN-2017, the patient had a headache and left lower quadrant abdominal pain. On 06-JAN-2017 through 09-JAN-2017, the patient had diarrhea, fever and chills. As of the date of this report the diarrhea had gone away, but the patient "still had symptoms coming to the middle through her rectum" and a decreased appetite developed on an unknown date in January 2017. On 10-JAN-2017, the patient sought medical attention and visited nurse practitioner office complaining about her symptoms. The nurse practitioner ordered unspecified blood work and a urinalysis. Both came back normal. The nurse practitioner recommended a bland diet and over the counter PEPCID or omeprazole. As of 18-JAN-2017, the the symptoms were improving but not gone except of diarrhea which was resolved on an unknown date in January 2017. It was reported, if the symptoms remain unresolved, the nurse practitioner would order a computer tomography (CT) scan. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 03-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU) refrigerated vial (injection) (route of administration, lot # and expiration date were not reported) for prevention of shingles. On 03-JAN-2017, the patient experienced redness and pain in the arm with an unspecified rash. On 04-JAN-2017, the patient had a headache and left lower quadrant abdominal pain. On 06-JAN-2017 through 09-JAN-2017, the patient had diarrhea, fever and chills. As of the date of this report the diarrhea had gone away, but the patient "still had symptoms coming to the middle through her rectum" and a decreased appetite developed on an unknown date in January 2017. On 10-JAN-2017, the patient sought medical attention and visited nurse practitioner office complaining about her symptoms. The nurse practitioner ordered unspecified blood work and a urinalysis. Both came back normal. The nurse practitioner recommended a bland diet and over the counter PEPCID or omeprazole. As of 18-JAN-2017, the the symptoms were improving but not gone except of diarrhea which was resolved on an unknown date in January 2017. It was reported, if the symptoms remain unresolved, the nurse practitioner would order a computer tomography (CT) scan. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding her peritnent medical history, drug reactions/ allergies, and concomitant medications was not provided. On 10-AUG-2016, the patient was vaccinated with the first dose of VAQTA and this was followed by a second dose on 30-JAN-2017; both of which were administered intramuscularly and indicated for prophylaxis (the dose, frequency, anatomical location, lot # and expiration date for both vaccines were unknown). Despite this schedule of administrations, the patient did not report any side effects. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to two female patients of unknown age. The concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with the first dose of ZOSTAVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prevention of shingles (prophylaxis). There were no concomitant therapies reported. The reporter stated that, on an unknown date after receiving ZOSTAVAX, the patients developed shingles. No product quality complaint was involved. The outcome of herpes zoster was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Myalgia, Nausea, Sleep disorder, Vomiting
Clinical narrative: Woke up feeling nauseous and having muscle aches, vomited. Slept fitfully & didn't go to work because I had all the classic flu symptoms when I got out of bed. Didn't eat but drank small quantities of water. Vomited again around 2 PM. Sipped water & PEDIALYTE until around 6 PM and vomited again. Continued sipping water & PEDIALYTE throughout evening & went to bed about midnight. Woke up feeling much improved & hopefully over the adverse reaction.
Age: 1.42
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None noted at this time.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Somnolence
Clinical narrative: Telephone call from grandmother states infant is lethargic and has been since vaccine. He wont wake up. But she did say he has taken a bottle. Instructed to take infant to ER or Dr. immediately.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Redness, warmth, and described "hardness" around entire red area.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, warmth, and described "hardness" around entire red area.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: After being administered the vaccine, patient noticed a 9x4 inch erythema directly under the armpit. The erythema was warm to touch, swollen and tender. Patient went to the doctors office and saw a nurse practitioner on Wednesday (2/1/17) who stated that patient has a history of using Humira.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt states on Friday, 1/27 she went to clinic to get her Hep B vaccine for work and has now broken out in a rash on her left side neck. Pt called clinic to let them know about the rash and they told her to come in again so they can check her. Pt states she received the vaccine because she needed one for work in order to be up to date. Pt states the rash started Saturday or Sunday.
Age: 21.0
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 21 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 11-JAN-2017, the patient was vaccinated with a dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported). On 12-JAN-2017, less than 24 hours after previous vaccination, the patient was vaccinated with a dose of VARIVAX injection, lot # M000996 with expiry date 07-JAN-2018 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified 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 dates, the patients were vaccinated with an improperly stored doses of M-M-R II (albumin status not reported) (doses, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of M-M-R II experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, time and temperatures of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012038: US-009507513-1701USA012037: US-009507513-1701USA012035: US-009507513-1701USA009285.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Fall, Head injury, Postictal state, Seizure
Clinical narrative: Initial unsolicited report received from a physician on 20 Jan 2017. This case involves a 12-year-old male patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose, dose in series, and site of administration were not reported) intramuscularly on 20 Jan 2017. Illness at the time of vaccination was reported as reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions Attention deficit hyperactivity disorder (ADHD) and no known drug allergy. Concomitant medications were not reported. On 20 Jan 2017, same day, following the vaccination, the patient had developed a seizure, He fell to the floor and hit his head in the occipital and temporal area, he was brought back into the office and made to lay down and observed, the post ictal period lasted for few minutes, was lying down for 10 minutes after that, he sat up and was feeling dizzy and again he laid down for 10 min, then sat up then seemed more stable. He returned home with his parent and vomited once there. The physician advised that, the patient should be seen in the Emergency room. The physician met the family at the ER. The patient was being evaluated. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: seizure. List of documents held by sender: none. Sender's Comments: Patient was vaccinated MENACTRA and had seizure which is unlisted, due to which he fell down and hits his head and vomited after some time. Time to onset is compatible, additional information regarding patient medical history, previous similar episode, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a physician on 20 Jan 2017. This case involves a 12-year-old male patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose, dose in series, and site of administration were not reported) intramuscularly on 20 Jan 2017. Illness at the time of vaccination was reported as reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions Attention deficit hyperactivity disorder (ADHD) and no known drug allergy. Concomitant medications were not reported. On 20 Jan 2017, same day, following the vaccination, the patient had developed a seizure, He fell to the floor and hit his head in the occipital and temporal area, he was brought back into the office and made to lay down and observed, the post ictal period lasted for few minutes, was lying down for 10 minutes after that, he sat up and was feeling dizzy and again he laid down for 10 min, then sat up then seemed more stable. He returned home with his parent and vomited once there. The physician advised that, the patient should be seen in the Emergency room. The physician met the family at the ER. The patient was being evaluated. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: seizure. List of documents held by sender: none. Sender's Comments: Patient was vaccinated MENACTRA and had seizure which is unlisted, due to which he fell down and hits his head and vomited after some time. Time to onset is compatible, additional information regarding patient medical history, previous similar episode, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Chest pain, Heart rate irregular
Clinical narrative: Initial unsolicited report received from a patient on 25 January 2017. This case involves a male patient (onset age unknown) who was vaccinated intramuscularly with a dose of SMALLPOX (batch number, expiry date, dose and dose in series were not reported) and ANTHRAX (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 20 January 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA) and Illness at the time of vaccination were reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified time following the vaccination, the patient had developed chest pain and pressure with irregular heartbeat and was advised to immediately call on 911 or Medics on the base to get to an emergency response. Laboratory investigations was not reported. No corrective treatment was reported. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cataract operation, Hypersensitivity, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Pt received two vaccine 1/31/17. HIGH DOSE INFLUENZA, right upper deltoid, IM. PCV-13, left upper deltoid, IM. Pt walked into clinic today and reported allergic reaction. Pt evaluated by provider. Pt reports tenderness, swelling, and warmth, RUD. Denies fever, chills, SOB. Pt had cataract surgery 2/1/17 the morning after injections given. Provider treated patient for cellulitis of right upper extremity. DYNAMEN 500 mg PO 4 times daily x 10.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site warmth
Clinical narrative: Pt received two vaccine 1/31/17. HIGH DOSE INFLUENZA, right upper deltoid, IM. PCV-13, left upper deltoid, IM. Pt walked into clinic today and reported allergic reaction. Pt evaluated by provider. Pt reports tenderness, swelling, and warmth, RUD. Denies fever, chills, SOB. Pt had cataract surgery 2/1/17 the morning after injections given. Provider treated patient for cellulitis of right upper extremity. DYNAMEN 500 mg PO 4 times daily x 10.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Oral herpes, Pain, Pain in extremity
Clinical narrative: Pt displayed swelling and pain at the site of injection that persisted for 3 days.  Additionally, patient experienced periodic shooting pain down to her hand and fingers that has lasted over 3 weeks.  She also developed a fever blister on her lip.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomiting 3-4 times beginning at 2:00 AM seen in office at 10:15 am; PEDIALYTE prescribed and ZOFRAN.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Increased upper airway secretion, Influenza, Laboratory test normal, Nasopharyngitis, Streptococcus test negative
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 59-year-old male patient who received FLUARIX QUADRIALENT (batch number L2DR5, expiry date 7th May 2017). Concurrent medical conditions included blood pressure high. Concomitant products included Albuterol, FLOVENT HFA and Triamterene + Hydrochlorothiazide. On 26th August 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza a virus infection, cold and throat secretion increased. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza a virus infection and throat secretion increased were not recovered/not resolved and the outcome of the cold was recovered/resolved. The reporter considered the vaccination failure, influenza a virus infection and throat secretion increased to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the cold to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The patient's concomitant medications also included Multivitamins (MVI). The reporter stated that he received a Flu vaccine in his left deltoid, but was just recently diagnosed with influenza a at an urgent care facility. He had also been prescribed TAMIFLU for 5 days, Hydrocodone and PROVENTIL. He stated prior to being diagnosed, he had a cold that actually had cleared up for 2 to 3 days before he developed drainage in his throat and flu symptoms. He was also tested for pneumonia and streptococcus, which were both negative. The patient had planned to file an adverse event with the Food and Drug Administration (FDA). He was noted very knowledgeable about FDA adverse event filing as he had previously worked with some pharmaceuticals and at the reporting time was working in a medical device company. The case was considered as suspected vaccination failure since the exact time to onset for the events and confirmatory lab test details were not provided.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 59-year-old male patient who received FLUARIX QUADRIALENT (batch number L2DR5, expiry date 7th May 2017). Concurrent medical conditions included blood pressure high. Concomitant products included Albuterol, FLOVENT HFA and Triamterene + Hydrochlorothiazide. On 26th August 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza a virus infection, cold and throat secretion increased. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza a virus infection and throat secretion increased were not recovered/not resolved and the outcome of the cold was recovered/resolved. The reporter considered the vaccination failure, influenza a virus infection and throat secretion increased to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the cold to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The patient's concomitant medications also included Multivitamins (MVI). The reporter stated that he received a Flu vaccine in his left deltoid, but was just recently diagnosed with influenza a at an urgent care facility. He had also been prescribed TAMIFLU for 5 days, Hydrocodone and PROVENTIL. He stated prior to being diagnosed, he had a cold that actually had cleared up for 2 to 3 days before he developed drainage in his throat and flu symptoms. He was also tested for pneumonia and streptococcus, which were both negative. The patient had planned to file an adverse event with the Food and Drug Administration (FDA). He was noted very knowledgeable about FDA adverse event filing as he had previously worked with some pharmaceuticals and at the reporting time was working in a medical device company. The case was considered as suspected vaccination failure since the exact time to onset for the events and confirmatory lab test details were not provided.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Influenza, Influenza A virus test positive, Influenza B virus test positive, Oropharyngeal pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 4-year-old female patient who received FLUARIX QUADRIVALENT (batch number TS5F3, expiry date 30th June 2017). On 19th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 13th January 2017, 116 days after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, fever, cough, runny nose and sore throat. On an unknown date, the outcome of the vaccination failure, influenza, fever, cough, runny nose and sore throat were unknown. It was unknown if the reporter considered the vaccination failure, influenza, fever, cough, runny nose and sore throat to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received the vaccine in her left arm. The patient underwent a throat swab test and found to be positive for influenza type A and type B. The case was considered as suspected vaccination failure since the information regarding vaccination schedule which the patient was following was unknown.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rhinorrhoea, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 4-year-old female patient who received FLUARIX QUADRIVALENT (batch number TS5F3, expiry date 30th June 2017). On 19th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 13th January 2017, 116 days after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, fever, cough, runny nose and sore throat. On an unknown date, the outcome of the vaccination failure, influenza, fever, cough, runny nose and sore throat were unknown. It was unknown if the reporter considered the vaccination failure, influenza, fever, cough, runny nose and sore throat to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received the vaccine in her left arm. The patient underwent a throat swab test and found to be positive for influenza type A and type B. The case was considered as suspected vaccination failure since the information regarding vaccination schedule which the patient was following was unknown.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Paraesthesia
Clinical narrative: Pt c/o Facial tingling, weakness, Fatigue.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Erythema, Hypoaesthesia, Joint stiffness, Mobility decreased
Clinical narrative: Swollen hands, sore stiff fingers and joints. Numbness and tingling; generally in early morning hours is worse. Always upon waking, symptoms especially worse in left hand At first, both hands swelled up like catchers mitts!! I'm still trying to get help regarding an adverse reaction to a vaccination that was done February 3, 2015. I still suffer moderately swollen hands with stiff joints and some numbness and tingling, and in the morning I cannot close my hands tight enough to make a fist a couple of hours. This has occurred ever since the MMR vaccination. In the beginning my hands swelled up like catcher's mitts. I could not close my hands, or bend my fingers; they were red and swollen and the pain was severe. Significant tingling and numbness occurred day and night, and lasted for several weeks. It took a long tim to be able to use my hands, particularly my left hand, but some symptoms still linger. My left hand is still weakened, and some numbness and tingling frequently occurs. I believe you need to know about this rare side effect and that it is still ongoing. I have been patient, hoping this would go away, but it has lasted so long it appears to be permanent, and restricts my activities. I have not received any reply from either your office or any other entity involved in this. I had seen my previous family physician regarding these symptoms when they first occurred. He was later re-assigned to another medical agency and his replacement was subsequently replaced by some other temporary physician. I permanently changed over to a medical office specializing in senior medical care, due to my age. I would never have had this shot in the first place, as I was never vaccinated for any disease, due to my background. However, as I was on my way to visit relatives infant during the measles outbreak, I was advised to vaccinate.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Swollen hands, sore stiff fingers and joints. Numbness and tingling; generally in early morning hours is worse. Always upon waking, symptoms especially worse in left hand At first, both hands swelled up like catchers mitts!! I'm still trying to get help regarding an adverse reaction to a vaccination that was done February 3, 2015. I still suffer moderately swollen hands with stiff joints and some numbness and tingling, and in the morning I cannot close my hands tight enough to make a fist a couple of hours. This has occurred ever since the MMR vaccination. In the beginning my hands swelled up like catcher's mitts. I could not close my hands, or bend my fingers; they were red and swollen and the pain was severe. Significant tingling and numbness occurred day and night, and lasted for several weeks. It took a long tim to be able to use my hands, particularly my left hand, but some symptoms still linger. My left hand is still weakened, and some numbness and tingling frequently occurs. I believe you need to know about this rare side effect and that it is still ongoing. I have been patient, hoping this would go away, but it has lasted so long it appears to be permanent, and restricts my activities. I have not received any reply from either your office or any other entity involved in this. I had seen my previous family physician regarding these symptoms when they first occurred. He was later re-assigned to another medical agency and his replacement was subsequently replaced by some other temporary physician. I permanently changed over to a medical office specializing in senior medical care, due to my age. I would never have had this shot in the first place, as I was never vaccinated for any disease, due to my background. However, as I was on my way to visit relatives infant during the measles outbreak, I was advised to vaccinate.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling
Clinical narrative: Swollen hands, sore stiff fingers and joints. Numbness and tingling; generally in early morning hours is worse. Always upon waking, symptoms especially worse in left hand At first, both hands swelled up like catchers mitts!! I'm still trying to get help regarding an adverse reaction to a vaccination that was done February 3, 2015. I still suffer moderately swollen hands with stiff joints and some numbness and tingling, and in the morning I cannot close my hands tight enough to make a fist a couple of hours. This has occurred ever since the MMR vaccination. In the beginning my hands swelled up like catcher's mitts. I could not close my hands, or bend my fingers; they were red and swollen and the pain was severe. Significant tingling and numbness occurred day and night, and lasted for several weeks. It took a long tim to be able to use my hands, particularly my left hand, but some symptoms still linger. My left hand is still weakened, and some numbness and tingling frequently occurs. I believe you need to know about this rare side effect and that it is still ongoing. I have been patient, hoping this would go away, but it has lasted so long it appears to be permanent, and restricts my activities. I have not received any reply from either your office or any other entity involved in this. I had seen my previous family physician regarding these symptoms when they first occurred. He was later re-assigned to another medical agency and his replacement was subsequently replaced by some other temporary physician. I permanently changed over to a medical office specializing in senior medical care, due to my age. I would never have had this shot in the first place, as I was never vaccinated for any disease, due to my background. However, as I was on my way to visit relatives infant during the measles outbreak, I was advised to vaccinate.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 05-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies were not provided. On 17-JAN-2017,  the patient was vaccinated with an improperly stored ROTATEQ orally, (strength, dose, and frequency were not reported),  lot # M019706, and expiration date 24-OCT-2017, for prophylaxis. The reporter stated that the temperature range of the vaccine was between  >46°F to <77°F, exact range 47F to 50F and the time frame was 73 hours, also she stated that there was not previous temperature excursion, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: This is a spontaneous report received from a pharmacist who reported on an unknown patient (gender unknown) who received a dose of ZOSTAVAX on an unspecified date. The pharmacist reported that the patient developed 'gout' on an unspecified date about 'two weeks' following the administration of ZOSTAVAX. The patient sought unspecified medical attention. There was no treatment provided for the adverse event. The outcome was unknown. 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 Medical Assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. In December 2016, the patient was vaccinated with an unspecified improperly stored dose of GARDASIL for prophylaxis (lot number K011562 with expiration date of 08-APR-2017) (strength, dosage schedule, route of administration and anatomical location were not reported). No concomitant medications were provided. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion of 35.4 degree Fahrenheit (F) and 34.9 F for 96 hours and 72 hours. The aforementioned temperature was no identified due to a data logger. There were no previous temperature excursions. Furthermore, no product quality complaint was involved. Additional information has been requested.