chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site inflammation, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: On 9/16: 3 hr after getting TRUEMBA shot on (L) upper arm, dev. pain/inflammation/swelling on lower area of (L) arm not site of injection child also has fever/chills. Highest 102-103. Last fever was 4am today 9/18 been taking Ibuprofen/TYLENOL otherwise no other symp no headache nausea/vom/diar/dizziness/is feeling better swelling decreased slightly.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity received first dose of PREVNAR 13, (Lot R94917, expiration date May2018, NDC number: 00005-1971-02), intramuscular in right deltoid on 03Sep2017 16:03 at 0.5 ml, single for immunisation.  Medical history included allergies to penicillin and sulfa. Family history was none.  The patient's concomitant medications were not reported. The patient had some discomfort for the actual metal needle going in on 03Sep2017. The event was non-serious. The patient experienced lifting arm above head is painful, had limited range of motion, soreness and stiffness on 05Sep2017. The events lifting arm above head is painful, had limited range of motion and soreness were considered medically significant and related to pneumococcal 13-val conjugate vaccine. The event stiffness was non- serious. No relevant test done. The outcome of the events lifting arm above head is painful, had limited range of motion, stiffness, some discomfort for the actual metal needle going in, was unknown. The outcome of the event soreness was recovering.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "lifting arm above head is painful, had limited range of motion and soreness" cannot be fully excluded. Local reaction such as vaccination site pain with limitation in movement at vaccinated limb are the known risks for PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site discomfort, Joint range of motion decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity received first dose of PREVNAR 13, (Lot R94917, expiration date May2018, NDC number: 00005-1971-02), intramuscular in right deltoid on 03Sep2017 16:03 at 0.5 ml, single for immunisation.  Medical history included allergies to penicillin and sulfa. Family history was none.  The patient's concomitant medications were not reported. The patient had some discomfort for the actual metal needle going in on 03Sep2017. The event was non-serious. The patient experienced lifting arm above head is painful, had limited range of motion, soreness and stiffness on 05Sep2017. The events lifting arm above head is painful, had limited range of motion and soreness were considered medically significant and related to pneumococcal 13-val conjugate vaccine. The event stiffness was non- serious. No relevant test done. The outcome of the events lifting arm above head is painful, had limited range of motion, stiffness, some discomfort for the actual metal needle going in, was unknown. The outcome of the event soreness was recovering.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "lifting arm above head is painful, had limited range of motion and soreness" cannot be fully excluded. Local reaction such as vaccination site pain with limitation in movement at vaccinated limb are the known risks for PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 74-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient did not have any past drug reactions or allergies. On 11-SEP-2017, the patient was vaccinated with PNEUMOVAX23 intramuscularly, lot # M038216, expiration date: 09-MAY-2018 (dose was not reported) for prophylaxis. On 12-SEP-2017, the patient experienced pain, warmth and swelling from the injection site down to the elbow. No treatment was given for the events. No lab diagnostics were performed. The outcome of pain, warmth and swelling from the injection site down to the elbow was reported as not recovered on an unknown date. The causality assessment was not provided.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 74-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient did not have any past drug reactions or allergies. On 11-SEP-2017, the patient was vaccinated with PNEUMOVAX23 intramuscularly, lot # M038216, expiration date: 09-MAY-2018 (dose was not reported) for prophylaxis. On 12-SEP-2017, the patient experienced pain, warmth and swelling from the injection site down to the elbow. No treatment was given for the events. No lab diagnostics were performed. The outcome of pain, warmth and swelling from the injection site down to the elbow was reported as not recovered on an unknown date. The causality assessment was not provided.
Age: 24.0
Sex: F
Vaccine: FLUR3
Symptoms: Herpes zoster, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: About two days after I received the flu shot, I noticed that my back was itchy. A day later, a rash appeared and got bigger. I visited my PCP and he confirmed that it was shingles. Treatment included VALTREX and anti-itch OTC lotions. Signs: itching, red painful rash that was characteristic of shingles, shingles rash spread to inner right arm as well. Time course: less than 2 weeks.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Urticaria, White blood cell count
Clinical narrative: Added one more by mistake. Did not know how to delete it.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Photophobia, Pyrexia
Clinical narrative: Muscle aches ongoing, low grade fever, sensitivity to light.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unspecified doses of improperly stored GARDASIL 9 lot # M023169 and expiration date 13-JUN-2018 (dose and frequency was not reported) for prophylaxis. No adverse effect reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA012429:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. The patient's concurrent condition, historical condition and concomitant therapy were not reported. On 29-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, strength, route and expiration date unknown, lot# M011117) for prophylaxis. On 16-JUN-2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot# N001533). On 22-AUG-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot# N010497) (Inappropriate schedule of drug administration). No adverse effect reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report has been received from a nurse practitioner concerning two unspecified patients of unknown age an gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with GARDASIL, intramuscularly (lot# and expiration date unknown) for prevent against human papillomavirus (HPV). The patients received unspecified doses of GARDASIL. On unknown dates, the patients were detected as positive for unspecified human papilloma virus (HPV) types. Outcome of the event was not reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1708USA012097:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age. The patients' medical history and concurrent condition were not reported. On an unknown date, an unspecified number of patients were administered improperly stored PROQUAD (Lot# N010247, expiration date 25-SEP-2018) (dose, frequency and route were not reported) that was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration date unknown).  The vaccine was exposed to temperature excursion of 6 Fahrenheit (F) to 14 F for 15 hours and the data logger was not involved. The vaccine was previous exposed to a temperature excursion of 6 F to 14 F for 164 hours. No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA, 0.5 mL, lot # M018644, expiration date 20-SEP-2017, or M033611 02-MAR-2018 (strength and route of vaccination were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to temperature 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs;  07-JUN-2017, to 47°F for 18 hrs; on  09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. Adverse effects were not reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1709USA008836: US-009507513-1709USA008835: US-009507513-1709USA008833: US-009507513-1709USA008834:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent  conditions and concomitant therapies were not provided. On multiple dates between 20-APR-2016 and 20-MAY-2016, the patients were vaccinated with incorrect stored doses of GARDASIL 9 (strength, dose, lot# and expiration date were not provided) for prophylaxis. On an unspecified date in 2016, the doses of GARDASIL 9 underwent a temperature excursion from 47 Fahrenheit degrees to 77 Fahrenheit degrees along 32 minutes. The call was placed because of a Digital Data Logger. The GARDASIL 9 had not experienced previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008180: US-009507513-1709USA008179: US-009507513-1709USA008178:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to 5 patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 16-JUN-2017, 04-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M011117, expiration date 12-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 207 hours and 47 to 77 degrees Fahrenheit for 207 hours. Data logger was involved in recording of the temperature excursions. There was a previous temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours reported. This is one of two reports received from the same reporter.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report has received from a pharmacist referring to a 63 year old female patient with stomach reflux and latex sensitivity. No information was provided regarding the patient medical history. On 06-SEP-2017, the patient was vaccinated with ZOSTAVAX (strength and dose were not provided) lot # N012492, expiration date 17-MAR-2018, in the right arm for prophylaxis.  Other suspect therapies included sterile diluent (MRK), lot#M013638, expiration date 19-NOV-2018. Concomitant medication included an unspecified medication for stomach reflux (unspecified details). On 07-SEP-2017, the patient experienced a reddened area the size of a baseball at the injection site. No laboratory diagnostics were performed. The outcome of injection site erythema was unknown. The causality between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and a licensed practical nurse referring to a patient of unknown ageand gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 08-SEP-2017, the patient was vaccinated with a dose of GARDASIL 9, intramuscular, in the hip muscle (drug administered at inappropriate site), lot # N017832; expirtion date: 16-NOV-2019 (strength was not reported)  for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple unspecifed patients of an unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M035487, expiration date 23-FEB-2019 (strengtht, dose, frequency and route were not provided) for prophylaxis.  Data logger was involved. The temperature excursion was 34.1 F for a time frame of 45 minutes. No adverse effects reported. No product quality complaint was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent  conditions and concomitant therapies were not provided. On multiple dates between 20-APR-2016 and 20-MAY-2016, the patients were vaccinated with incorrect stored doses of ROTATEQ, for prophylaxis. The doses of ROTATEQ underwent temperature excursion from 47 Fahrenheit degrees to 77 Fahrenheit degrees along 32 minutes. The call was placed because of a Digital Data Logger. The ROTATEQ had not experienced previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-: US-009507513-1709USA008179: US-009507513-1709USA008180: US-009507513-1709USA004302:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent  conditions and concomitant therapies were not provided. On multiple dates between 20-APR-2016 and 20-MAY-2016, the patients were vaccinated with incorrect stored doses of RECOMBIVAX HB for prophylaxis. The doses of RECOMBIVAX HB underwent temperature excursion from 47 Fahrenheit degrees to 77 Fahrenheit degrees along 32 minutes. The call was placed because of a Digital Data Logger. The RECOMBIVAX HB had not experienced previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008180: US-009507513-1709USA008178: US-009507513-1709USA004302:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent  conditions and concomitant therapies were not provided. On multiple dates between 20-APR-2016 and 20-MAY-2016, the patients were vaccinated with incorrect stored doses of VAQTA for prophylaxis. The doses of VAQTA underwent temperature excursion from 47 Fahrenheit degrees to 77 Fahrenheit degrees along 32 minutes. The call was placed because of a Digital Data Logger. The VAQTA had not experienced previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA004302: US-009507513-1709USA008178: US-009507513-1709USA008179.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M039317, expiration date 20-SEP-2018 (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MRK). On an unspecified date, the vaccines were exposed to temperature ranges between 6° Fahrenheit (F) to 14° during a time frame of 1 hour 20 minutes. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported. This is one of two reports from the same source. Sender's Comments: US-009507513-1709USA008861.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 19 unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates in 2017, after 15-JUN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M041766, expiration date 08-MAY-2018 (strength, dose and dose number were not provided) for prophylaxis. On an unspecified date, the vaccines were exposed to temperature ranges between 32° Fahrenheit (F) to 35° (34.7°F) one cycle during a time frame of 12 hours. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 27-OCT-2016 (also reported as "after that date"), the patient were vaccinated with an unspecified number of doses of improperly stored of PROQUAD lot number L030584, expiration date: 10-FEB-2017 (strength, dose and route were not reported) for prophylaxis. It was reported that the sterile diluent (manufacturer unknown) did not undergo a temperature excursion. The temperature of excursion with  PROQUAD was 6 to 14 Fahrenheit degrees during 5 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by data logger. No adverse effects were reported.; Sender's Comments: US-009507513-1709USA008827:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # N000336, expiration date 03-JUL-2018, dose and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion -9 degrees Celsius to 8 degrees Celsius for 6 hours and 18 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010812:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 27-OCT-2016 (also reported as "after that date"), the patient were vaccinated with an unspecified number of doses of improperly stored of VARIVAX lot number M018436 expiration date: 13-FEB-2017 or L046888, expiration date; 23-NOV-2017 (strength, dose and route were not reported) for prophylaxis. It was reported that the sterile diluent (manufacturer unknown) did not undergo a temperature excursion. The temperature of excursion with VARIVAX was 6 to 14 Fahrenheit degrees during 5 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by data logger. No adverse effects were reported. Sender's Comments: US-009507513-1709USA008679.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # M040412, expiration date 30-JUN-2019, and/or lot # M043731, expiration date 22-JUN-2019 (strength, dose number and route of administration vaccination were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to temperature 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs;  07-JUN-2017, to 47°F for 18 hrs; on  09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. Adverse effects were not reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1709USA008835: US-009507513-1709USA008834: US-009507513-1709USA008836: US-009507513-1709USA004111:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # L018501, expiration date 22-JUN-2017, or lot # L033343, exp. date 13-SEP-2017, and/or lot # L048848 exp. date 09-AUG-2018(strength, dose number and route of administration were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to temperature 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs; 07-JUN-2017, to 47°F for 18 hrs; on 09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. It was not reported if the administered vaccines were exposed to all temperature excursions. Adverse effects were not reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA008835: US-009507513-1709USA004111: US-009507513-1709USA008836: US-009507513-1709USA008833.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M031802, expiration date 09-NOV-2017, and/or lot # M041181 exp. date 31-MAY-2018 (strength and dose number were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to a temperature of 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs; 07-JUN-2017, to 47°F for 18 hrs; on 09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. Adverse effects were not reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA008835: US-009507513-1709USA008834: US-009507513-1709USA004111: US-009507513-1709USA008833.
Sex: U
Vaccine: HPV9
Symptoms: Pain, Polycystic ovaries, Vaginal haemorrhage
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as "nurse prescriber") via a field representative, concerning an anonymous patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis. Then, after GARDASIL 9 administration, the patient experienced chronic pain and increased of vaginal bleeding (dates unspecified); and finally was diagnosed with polycystic ovary disease. No product quality complaint (PQC) was involved. The outcome of the polycystic ovary disease was not reported. The causal relationship between the polycystic ovary disease and the GARDASIL 9 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown gender and age. The patients' concurrent condition and medical history were not reported. On unknown dates, an unknown number of patients were vaccinated with improperly stored PROQUAD (dose and route unknown, lot # N004629, expiration date 07-AUG-2018) for prophylaxis. It was unknown if the sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. The vaccine was improperly stored at 6 to 14 degrees Fahrenheit for 51 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 3 hours. The phone call was a result of the data logger. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA000676: US-009507513-1709USA009052.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 15-JUN-2017, 22-JUN-2017, 04-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M035828, expiration date 28-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 207 hours and 47 to 77 degrees Fahrenheit for 207 hours. Data logger was involved in recording of the temperature excursions. There was a previous temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours reported.; Sender's Comments: US-009507513-1709USA004675:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to 2 unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-AUG-2017, 1 unspecified patient were vaccinated with improperly stored PROQUAD (Lot# N002325, expiration date 19-JUL-2018) (strength, dose, and route unknown) for prophylaxis, the diluent (unspecified lot #'s and expiration dates) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009153: US-009507513-1709USA009152: US-009507513-1709USA009150: US-009507513-1708USA008578: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye swelling, Eyelid oedema, Lip swelling, Nausea
Clinical narrative: Lab Asst obtained this year's flu vaccine in her left arm at 0830. About 15 minutes later patient noticed throat swelling, nose swelling, pt was unable to breathe, and had severe nausea. Pt reported to her PMD at the clinic and received an EPIPREN. At about 1300 pt noticed recurrence of symptoms with no relief from oral BENADRYL. Pt experienced nausea, vomiting, throat swelled shut, upper lip swelled, eyes were also puffy. Pt reported to her PMD at the clinic and got another EPIPEN injection as well as a dose of prednisone. At 2030 pt experienced yet another reoccurrence of these symptoms, more severe than the last episode with no relief of oral medication. Symptoms were so unrelenting that pt reported to ED. She was admitted to ED from 9/15/17 and discharged 9/16/17 -pt has NEVER reacted to flu vaccine before at all in any fashion.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Vomiting
Clinical narrative: Lab Asst obtained this year's flu vaccine in her left arm at 0830. About 15 minutes later patient noticed throat swelling, nose swelling, pt was unable to breathe, and had severe nausea. Pt reported to her PMD at the clinic and received an EPIPREN. At about 1300 pt noticed recurrence of symptoms with no relief from oral BENADRYL. Pt experienced nausea, vomiting, throat swelled shut, upper lip swelled, eyes were also puffy. Pt reported to her PMD at the clinic and got another EPIPEN injection as well as a dose of prednisone. At 2030 pt experienced yet another reoccurrence of these symptoms, more severe than the last episode with no relief of oral medication. Symptoms were so unrelenting that pt reported to ED. She was admitted to ED from 9/15/17 and discharged 9/16/17 -pt has NEVER reacted to flu vaccine before at all in any fashion.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling cold, Hyperhidrosis, Nausea
Clinical narrative: 10 hours after receiving vaccine I started to feel very weak and had very bad body aches. It was in the 90's outside, but I was freezing, so I took a hot bath and laid down. I was shivering uncontrollably and my fever spiked to 102 degrees. I took 2 ADVIL PM around 9 PM and went to sleep. I woke up at 3 AM in a pool of sweat and felt very weak and nauseous. Re-checked temperature at 9 AM the next day and it had returned to normal, though I still felt very weak, so I stayed home from work to rest that day. I had also received my weekly allergy shots that same day at 4:30 PM, but they said it was okay to do my allergy shots on the same day I had my flu vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: 10 hours after receiving vaccine I started to feel very weak and had very bad body aches. It was in the 90's outside, but I was freezing, so I took a hot bath and laid down. I was shivering uncontrollably and my fever spiked to 102 degrees. I took 2 ADVIL PM around 9 PM and went to sleep. I woke up at 3 AM in a pool of sweat and felt very weak and nauseous. Re-checked temperature at 9 AM the next day and it had returned to normal, though I still felt very weak, so I stayed home from work to rest that day. I had also received my weekly allergy shots that same day at 4:30 PM, but they said it was okay to do my allergy shots on the same day I had my flu vaccine.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 3 y.o. patient was given adult dose of Hep B vaccination. No adverse reactions were reported by parents or child's primary doctor. RN at Medical Group consulted with our clinic Doctor and spoke to parent's regarding possible side affects or reactions that could occur from receiving this adult does of the Hep B vaccine.
Age: 86.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: SWELLING, REDNESS, WARM TO TOUCH ON RIGHT ARM, AREA MEASURING 5" WIDE X 6.5" LONG. DEVELOPED 6-7 HRS AFTER INJECTION.
Age: 86.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: SWELLING, REDNESS, WARM TO TOUCH ON RIGHT ARM, AREA MEASURING 5" WIDE X 6.5" LONG. DEVELOPED 6-7 HRS AFTER INJECTION.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Chest pain, Deafness, Dysphagia
Clinical narrative: Initially pain in mid back, they thought he had a muscle strain, urgent care gave him a shot of some kind, then went to the ER a day or two later on 9/4 because of the same back pain but it was much worse. His d/c summ says there was chest pain, which he did have but went  away. When I saw him 9/8/17, he reported the pain as everywhere, upper and lower back, hips and legs. Stated he has noted that he can't close his eyes all the way to sleep for 3 days. He can't swallow, food keeps coming back up. Drank water with a straw only and small amounts. Hadn't eaten in 6d, but in the last day sister had made him have 1/2 bowl of soup and some Gatorade. Not urinating much as a result. He was reporting numbness in his fingertips and feet for 3 days. L eye has abnormal vision for 3 days. Things are "moving around", poss blurry.  He is deaf and the interpreter had a tough time understanding his meaning. He has had issues with dysphagia and had a 30lb weight loss over several months. He was sent to the ER again and admitted. Found to have pneumonia, suspected aspiration. Found to have GBS.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Eyelid function disorder, Guillain-Barre syndrome, Hypoaesthesia, Hypophagia
Clinical narrative: Initially pain in mid back, they thought he had a muscle strain, urgent care gave him a shot of some kind, then went to the ER a day or two later on 9/4 because of the same back pain but it was much worse. His d/c summ says there was chest pain, which he did have but went  away. When I saw him 9/8/17, he reported the pain as everywhere, upper and lower back, hips and legs. Stated he has noted that he can't close his eyes all the way to sleep for 3 days. He can't swallow, food keeps coming back up. Drank water with a straw only and small amounts. Hadn't eaten in 6d, but in the last day sister had made him have 1/2 bowl of soup and some Gatorade. Not urinating much as a result. He was reporting numbness in his fingertips and feet for 3 days. L eye has abnormal vision for 3 days. Things are "moving around", poss blurry.  He is deaf and the interpreter had a tough time understanding his meaning. He has had issues with dysphagia and had a 30lb weight loss over several months. He was sent to the ER again and admitted. Found to have pneumonia, suspected aspiration. Found to have GBS.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle strain, Pain in extremity, Pneumonia aspiration, Urine output decreased, Visual impairment
Clinical narrative: Initially pain in mid back, they thought he had a muscle strain, urgent care gave him a shot of some kind, then went to the ER a day or two later on 9/4 because of the same back pain but it was much worse. His d/c summ says there was chest pain, which he did have but went  away. When I saw him 9/8/17, he reported the pain as everywhere, upper and lower back, hips and legs. Stated he has noted that he can't close his eyes all the way to sleep for 3 days. He can't swallow, food keeps coming back up. Drank water with a straw only and small amounts. Hadn't eaten in 6d, but in the last day sister had made him have 1/2 bowl of soup and some Gatorade. Not urinating much as a result. He was reporting numbness in his fingertips and feet for 3 days. L eye has abnormal vision for 3 days. Things are "moving around", poss blurry.  He is deaf and the interpreter had a tough time understanding his meaning. He has had issues with dysphagia and had a 30lb weight loss over several months. He was sent to the ER again and admitted. Found to have pneumonia, suspected aspiration. Found to have GBS.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Initially pain in mid back, they thought he had a muscle strain, urgent care gave him a shot of some kind, then went to the ER a day or two later on 9/4 because of the same back pain but it was much worse. His d/c summ says there was chest pain, which he did have but went  away. When I saw him 9/8/17, he reported the pain as everywhere, upper and lower back, hips and legs. Stated he has noted that he can't close his eyes all the way to sleep for 3 days. He can't swallow, food keeps coming back up. Drank water with a straw only and small amounts. Hadn't eaten in 6d, but in the last day sister had made him have 1/2 bowl of soup and some Gatorade. Not urinating much as a result. He was reporting numbness in his fingertips and feet for 3 days. L eye has abnormal vision for 3 days. Things are "moving around", poss blurry.  He is deaf and the interpreter had a tough time understanding his meaning. He has had issues with dysphagia and had a 30lb weight loss over several months. He was sent to the ER again and admitted. Found to have pneumonia, suspected aspiration. Found to have GBS.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At 0922 this morning the member reported that he had a localized swelling on his right deltoid to an anthrax immunization which was given 2 days ago. The reaction has redness to the area and warm to the touch. Reported to coast guard medical officer for followup. Patient will be defered in the medical readiness reporting system from future anthrax immunizations.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Muscle twitching
Clinical narrative: Client closed eyes, swayed to the right side while sitting and twitched for approximately 10 seconds. Then client was coherent and talking. Mom wanted 911 to come even though client was talking and coherent. 911 staff checked clients vitals and encouraged parent to take client to Emergency room if client had another episode like before. Nurse instructed parent and client to always tell staff when getting shots about passing out so precautions can be taken.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to 2 unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 07-AUG-2017, 2 unspecified patients were vaccinated with improperly stored PROQUAD (Lot# N002325, expiration date 19-JUL-2018) (strength, dose, and route unknown) for prophylaxis. The diluent (unspecified lot #'s and expiration dates) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009152: US-009507513-1709USA009151: US-009507513-1709USA009153: US-009507513-1709USA009150: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to 2 unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 10-AUG-2017, 3 different unspecified patients were vaccinated with improperly stored PROQUAD (Lot# N004631, expiration date 07-AUG-2018) (strength, dose, and route unknown) for prophylaxis, the diluent (unspecified lot #'s and expiration dates) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009153: US-009507513-1709USA009150: US-009507513-1709USA009151: US-009507513-1708USA008578: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE INCREASE REDNESS SWELLING W/O FEVER.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Herpes zoster, Rash
Clinical narrative: The patient reported that he had an active case of shingles that was treated with VALTREX 1 gram TID x 7 days. He reported that the treatment was effective in clearing up the rash. 20 days after starting treatment with VALTREX the patient received the ZOSTAVAX shot. He reported that the next day his Legs, back and arms started break out again. This was the same area that he reported the original rash had presented.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Bacterial test negative, Blood test normal, Electromyogram normal, Glucose urine absent, Headache
Clinical narrative: On January 7, 2017 (roughly two weeks after patient received the flu vaccine), I noticed patient was clenching his fists. Patient had never done this before. When I asked him why, he said it was because his hands were bothering him. I can send a timeline I have prepared, but over the next two weeks, the pain spread to his head (including at least two instances of blurry vision) and feet. We've had three blood tests since January 2017 (including one on January 21), an EMG and an MRI. The exams do not show a cause for his symptoms and patient continues to suffer from continuous hand and feet "tingling", as well as headaches. Medical Center Infectious Disease told us, there is "no way" his symptoms are caused by a bacteria or virus. At times, patient's symptoms become more painful. He has been seen by Medical Center Neurology, Infectious Disease and Immunology Departments. No definitive cause has been determined, but when I ask if it could be the flu vaccine, I have been told yes. Given that patient did not have a fever in December 2017 - April 2017 and his blood work does not show a bacterial or viral cause, the only cause my husband and I can think of is a potential adverse reaction to the flu vaccine. Medical journals note the flu vaccine may cause neurological issues and that such issues may present weeks after the vaccine. We have been told his symptoms may never go away. We are still seeking medical advice and will also visit the neurology department at another Hospital. I would be happy to submit copies of all medical exams done to date. Please note patient has no other developmental/emotional issues (no autism, disabilities, allergies).