chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a female patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Reporter reported that the patient in the office received her first dose patient GARDASIL 9 quadrivalent which was administered 4 years ago on unspecified date, lot # and expiration date unknown. Patient was administered second human papilloma virus (HPV) dose of GARDASIL 9 on 18-AUG-2017 (inappropriate schedule of drug administration). No adverse effects were reported and no additional information was given. The outcome of events was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date the patient was vaccinated with VARIVAX lot # N014368 for prophylaxis, which was exposed to temperature excursion of 15 to 46 (28) degrees Fahrenheit for 45 minutes. There were no previous temperature excursions. Data logger was involved. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown.The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. The pharmacist confirmed that the DILUENT (unknown lot#/exp. date) used to reconstitute the VARIVAX was properly stored. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009239:
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, dose, strength, lot # and expiry date not reported) for prophylaxis. Concomitant therapies included sterile diluent. The pharmacist reported that the patient received 3 doses of PNEUMOVAX 23, each dose on a different unspecified date (extra dose administered). No adverse effects reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to 4 patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates the patients were vaccinated with ZOSTAVAX lot # M042851 for prophylaxis, which were exposed to temperature excursion of 15 to 46 (28) degrees Fahrenheit for 45 minutes. There were no previous temperature excursions. Data logger was involved. On unknown dates the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. The pharmacist confirmed that the DILUENT (unknown lot#/exp. date) used to reconstitute the ZOSTAVAX was properly stored. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009030.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Pancreatic disorder
Clinical narrative: Patient said the day following her vaccination for Shingles, her blood sugar was 235. "It is never higher than 140 or 150 after I eat pie or cake." She said it went up as high as 335 the next day. She went to Dr., and he told her the live vaccine "shut down her pancreas" and the condition is "permanent" and if the new medicine he gives her doesn't bring it down, she will "have to go on insulin".  She could not remember the name of the new medication. Said it started with a J and he would be stopping her glipizide and probably her metformin. He told them to return to the health department and "have the director fill all a VAERS report".
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing, Local swelling, Pruritus
Clinical narrative: Allergic post injection reaction. Flushed, urticaria, swelling to neck, itchiness to neck, hands, feet, throat, mild dyspnea, transitory shortness of breath.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Allergic post injection reaction. Flushed, urticaria, swelling to neck, itchiness to neck, hands, feet, throat, mild dyspnea, transitory shortness of breath.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MNQ, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: In a health check, vaccines are given per protocol. Patient is attending an online school, but stated she needed vaccines as she would need for public school. Patient was behind on some vaccines. Patient was given vaccines needed as if she were going to public school and also for her health. Patient denied being pregnant, father signed permission for vaccines needed and, therefore, vaccines were administered. Patient was referred to Women's Clinic for birth control options. She stated she  had not missed a period and had been using condoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Dizziness postural, Headache, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: At 09:30AM, patient sitting upright in chair. Tdap and MENACTRA given separately, intramuscularly in left deltoid, then GARDASIL 9 given intramuscularly in right deltoid. Immediately after injection in right deltoid, patient had syncopal episode with slouched posture in chair. Nurse (RN) and patient's mom assisted in maintaining and supporting patient in upright position in chair. Syncopal episode duration approximately less than 10 seconds. Patient spontaneously recovered with verbal complaints of right upper arm pain and headache. Diaphoresis and facial palor noted. Patient complained of dizziness and nausea. Patient remained seated for 15 minutes, apple juice offered. Patient's mom reported that he has not had anything to eat or drink this morning. After 15 minutes, patient states that nausea has resolved, improvement in diaphoresis and facial palor noted. Patient stood up with assistance, still complained of slight dizziness upon standing. Patient remained seated for 5 more minutes. After 5 minutes, diaphoresis and facial palor resolved. Patient stood up again with assistance, denies dizziness, but still has a slight headache. Patient observed while walking around office, gait steady. Vaccine information statements reviewed again with patient?s mom, patient?s mom made aware of signs and symptoms that require immediate medical attention. At approximately 9:50AM, patient and his mom exited building.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Nausea, Pallor, Posture abnormal, Syncope
Clinical narrative: At 09:30AM, patient sitting upright in chair. Tdap and MENACTRA given separately, intramuscularly in left deltoid, then GARDASIL 9 given intramuscularly in right deltoid. Immediately after injection in right deltoid, patient had syncopal episode with slouched posture in chair. Nurse (RN) and patient's mom assisted in maintaining and supporting patient in upright position in chair. Syncopal episode duration approximately less than 10 seconds. Patient spontaneously recovered with verbal complaints of right upper arm pain and headache. Diaphoresis and facial palor noted. Patient complained of dizziness and nausea. Patient remained seated for 15 minutes, apple juice offered. Patient's mom reported that he has not had anything to eat or drink this morning. After 15 minutes, patient states that nausea has resolved, improvement in diaphoresis and facial palor noted. Patient stood up with assistance, still complained of slight dizziness upon standing. Patient remained seated for 5 more minutes. After 5 minutes, diaphoresis and facial palor resolved. Patient stood up again with assistance, denies dizziness, but still has a slight headache. Patient observed while walking around office, gait steady. Vaccine information statements reviewed again with patient?s mom, patient?s mom made aware of signs and symptoms that require immediate medical attention. At approximately 9:50AM, patient and his mom exited building.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: PATIENT HAS RED RAISED RASH ABOUT 3 INCHES IN DIAMETER AT INJECTION SITE AS WELL AS LATERALLY ACROSS THE CHEST - TREATED WITH BENEDRYL ORAL - RASH STILL THERE AFTER 4 DAYS BUT NO FURTHER AE.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Mobility decreased, Pain, Pyrexia
Clinical narrative: Report of trouble moving arm, fatigue and low fever.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' current conditions and medical history were not reported. On unknown dates the patients were vaccinated with doses of improperly stored M-M-R II (strength, dose and route of administration were not reported) lot # M029230, expiration date 08-MAY-2018, for prophylaxis. The vaccine was exposed to 9 degree celcius to 25 degree celcius for 35 hours (incorrect product storage). Properly stored sterile diluent (MERCK STERILE DILUENT) was used for reconstitution.There were no reported adverse events. There was no previous temperature excursions. Temperatures were tracked with data logger. There was no product quality complaint(PQC) involved.  Follow-up information was received via medical assistant on 18-AUG-2017. It was reported that one patient was vaccinated with M-M-R II, but did not have that information in front of her. She stated she would fax the patient identifiers and dates of vaccination for that patient. Patient details and narrative updated. This is one of the two cases received from same reporter.; Sender's Comments:  US-009507513-1708USA009300:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection, lot # M037655 with expiration date of 29-NOV-2017, lot # M041087 with expiration date of 03-JAN-2018 (dose and route of administration were not reported), which were reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of the vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 15 hours and 50 minutes. There were previous temperature excursions for zoster vaccine live (ZOSTAVAX) lot # M037655 of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 hours and 45 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. ZOSTAVAX lot # M041087 experienced a previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 7 hours and 45 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA006761:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse (LPN), referring to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot number M041770, expiration date 26-JUN-2018; lot number M045546, expiration date 12-JUN-2018; lot number reported as "N0047898", expiration date 31-OCT-2019; for prophylaxis. Lot number N0047898 is an invalid lot number for ROTATEQ. The data logger registered a temperature excursion of 47.49 Fahrenheit (F) for 13 minutes. There was not previous temperature excursion. No adverse effects were reported in any patients. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1708USA007538:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with VARIVAX lot # M028553 for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender.  No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # m030138 with expiry date: 15-JUN-2018 (dosing details, route unknown) for prophylaxis. The sterile diluent (unknown lot, unknown expiration) used for reconstitution did not undergo a temperature excursion. There was no previous temperature excursion. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 96 Hours 25 Minutes. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the two reported from the same reporter.; Sender's Comments: US-009507513-1708USA009347:
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N003993 with expiration date 20-OCT-2018 (dose was not reported), intramuscularly for prophylaxis. On the same day that night, the patient experienced swelling at injection site (injection site swelling) and took Aspirin, Medrol dose pack and kept ice packs on the injection site. The outcome of injection site swelling was reported as recovered. Causality assessment was not provided by the reporter.; Sender's Comments:  US-009507513-1708USA009384:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 60 year old female patient. The patient had no pertinent medical history and allergy/drug reactions. The patient was not taking any concomitant medications. On 15-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # N015627 with expiry date: 04-JUL-2018 (dosing details and route were unknown) for prophylaxis. Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) lot# M024782, expiry date: 23-FEB-2019 (dosing details, route and indication were not reported) used on the same date. On 18-AUG-2017, the patient experienced injection site reaction, and described it as feeling knotty (feeling abnormal). No treatment was given for the events. No lab tests were done. Action taken with sterile diluent(MERCK STERILE DILUENT) was unknown. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided by the reporter. There were no product quality complaints (PQC) involved.u
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 60 year old female patient. The patient had no pertinent medical history and allergy/drug reactions. The patient was not taking any concomitant medications. On 15-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # N015627 with expiry date: 04-JUL-2018 (dosing details and route were unknown) for prophylaxis. Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) lot# M024782, expiry date: 23-FEB-2019 (dosing details, route and indication were not reported) used on the same date. On 18-AUG-2017, the patient experienced injection site reaction, and described it as feeling knotty (feeling abnormal). No treatment was given for the events. No lab tests were done. Action taken with sterile diluent(MERCK STERILE DILUENT) was unknown. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided by the reporter. There were no product quality complaints (PQC) involved.u
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 18-AUG-2017, the patient was vaccinated with an expired PROQUAD lot # M007963, expiry date: 15-AUG-2017 (dosing details, route were unknown) for prophylaxis. PROQUAD had no temperature excursions prior to the administration. No adverse symptoms were reported. There were no product quality complaints (PQC) involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored VARIVAX (lot # L044526, Expiry date: 09-NOV-2017) for prophylaxis (dosing details were not reported). Concomitant therapies included sterile diluent. Temperature was reported as 6°F to 14°F (5.5°F) for 6 Hours 20 Minutes and -58°F to 5°F (1.5°F) for 5 Hours 15 Minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports from to the same reporter. Sender's Comments: US-009507513-1708USA009406.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a 5 year old patient of unknown gender. Information on medical history, past drugs, concurrent conditions and concomitant medications was not provided. On 17-AUG-2017, the patient received a dose of PROQUAD, (unknown lot, unknown expiration, unknown dose, frequency) reconstituted with sterile water diluent (unknown lot, unknown expiration, unknown dose, frequency) at an unspecified location and then on 18-AUG-2017, patient received another dose of PROQUAD reconstituted with sterile water diluent (unknown lot, unknown expiration) inadvertently (inappropriate schedule of vaccine administration) at a clinic. No adverse effects were reported. No further details were provided. Outcome of events was reported as unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (strength, dose and route of administration were not reported) lot # M040267, expiration date 14-MAY-2018, for prophylaxis. The vaccine was exposed to 9 degree celcius to 25 degree celcius for 35 hours. There were no reported adverse events. There was no previous temperature excursions. Temperatures were tracked with data logger. There was no product quality complaint(PQC) involved. This is one of the two reports received from same reporter.; Sender's Comments: US-009507513-1707USA006524:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # m034799 with expiry date: 01-FEB-2018 (dosing details, route unknown) for prophylaxis. The sterile diluent (lot# and expiration were unknown) used for reconstitution did not undergo a temperature excursion. There was no previous temperature excursion. It was reported that the vaccine was exposed to a temperature range of 47 F to 77 F for a duration of 14 hours 30 Minutes. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is second of the two reported reported from the same reporter.; Sender's Comments: US-009507513-1708USA008952:
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported), for prophylaxis. On the same day, the patient experienced swelling at injection site (injection site swelling). The outcome of injection site swelling was unknown. Causality assessment was not provided by the reporter.; Sender's Comments: US-009507513-1708USA008981:
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. This physician reported similar events for two patients. This is the first of two reports. A adolescent male patient of an unspecified ethnicity received single dose of TRUMENBA (Lot # S26962), via an unspecified route of administration on an unspecified date at an unspecified dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe vomiting within an hour of meningococcal group b rlp2086 and went to ER for assistance. The outcome of event was not reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017359849 same reporter/drug/event, different patient.
Sex: M
Vaccine: HPVX, MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar event for two patients. This is the second of two reports. An adolescent male patient of an unspecified ethnicity received TRUMENBA (lot #: S26962), via an unspecified route of administration on an unspecified date at a single dose for immunisation, and hpv vaccine, via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient had severe vomiting within an hour of meningococcal group b rlp2086 on an unspecified date, and patient went to emergency room (ER) for assistance. The outcome of event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017359848 same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales Representative. This physician reported same event for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date for immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced vomiting on an unspecified date. Event outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017362248 same reporter/drug/event, different patient.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported for two patients. This is the first of two reports. A 16-year-old male patient of an unknown race received TRUMENBA for immunization and MENACTRA on 07Aug2017 at single dose. On an unknown date the patient experienced a high fever of 104 degrees and had to be taken to the Emergency Room. It is unknown if he was admitted. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017360781 same reporter/product, different patient/event.
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales Representative. This Physician reported similar events for two patients. This is 2nd of two reports. This Physician reported for a patient that of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017360415 same reporter/drug/event, different patient.
Sex: F
Vaccine: RAB
Symptoms: Headache, Muscle tightness, Muscular weakness, Pyrexia
Clinical narrative: Initial unsolicited report received from consumer on 10 August 2017. This case involves a female patient (age was not reported) who was vaccinated with a second dose (also reported as first dose) of IMOVAX, first doses of IMMUNOGLOBULIN HUMAN ANTIRABIES (HRIG) and RABAVERT (Manufacture: GSK) (batch number: unknown, expiry date and site of administration were not reported) all intramuscularly on 04 Aug 2017. (vaccination date also reported as 08 Aug 2017). The patient's Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medication were not reported. Patient was fine on Monday and Tuesday. On 09 August 2017 (Wednesday), five days following the vaccination, the patient's legs felt tight and weak, first from the ankle to the knee then from the knee to the groin and funny ache in her head but not a headache and a low grade fever of 99 farad. Called trying to establish causation. Repeatedly informed her to be evaluated by a physician to determine cause. Other laboratory investigation and corrective treatment were not reported. Outcome of event was reported as unknown. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Feeling abnormal, Hyperhidrosis, Immediate post-injection reaction, Nervousness, Pallor
Clinical narrative: As soon as the nurse gave the patient the HPV vaccine the patient immediately stated that she felt "weird". Patient's mom stated that she was nervous and that she had not eaten this am.  Within 5 minutes the patient started to vomit, began sweating and became pale. Vital signs were assessed and were within normal range, NP came in and assessed patient. We provided patient with water and a cool cloth. The provider diagnosed her with having a vaso-vagal reaction. We monitored patient and she left the office a little before 10:30 as she was feeling better.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Presyncope, Vomiting
Clinical narrative: As soon as the nurse gave the patient the HPV vaccine the patient immediately stated that she felt "weird". Patient's mom stated that she was nervous and that she had not eaten this am.  Within 5 minutes the patient started to vomit, began sweating and became pale. Vital signs were assessed and were within normal range, NP came in and assessed patient. We provided patient with water and a cool cloth. The provider diagnosed her with having a vaso-vagal reaction. We monitored patient and she left the office a little before 10:30 as she was feeling better.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Aphasia, Asthenia, Chills, Electrocardiogram, Loss of consciousness
Clinical narrative: UNCONTROLLABLE CHILLS STARTED AT 5:30PM ACHES THROUGHOUT BODY WENT TO BED UNDER COVERS WITH NO WARMING WOKE AT 1 AM TO GO TO BATHROOM NAUSEA CAME OVER ME. THE NEXT THING I KNEW MY DAUGHTER WAS SCREAMING AT ME TO WAKE UP I HAD LOST CONSCIOUSNESS WITH SHAKING OF LEGS AND BODY FELT WEAK AND COULD NOT SPEAK RIGHT AWAY.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Nausea, Pain, Presyncope, Tremor, Vomiting
Clinical narrative: UNCONTROLLABLE CHILLS STARTED AT 5:30PM ACHES THROUGHOUT BODY WENT TO BED UNDER COVERS WITH NO WARMING WOKE AT 1 AM TO GO TO BATHROOM NAUSEA CAME OVER ME. THE NEXT THING I KNEW MY DAUGHTER WAS SCREAMING AT ME TO WAKE UP I HAD LOST CONSCIOUSNESS WITH SHAKING OF LEGS AND BODY FELT WEAK AND COULD NOT SPEAK RIGHT AWAY.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-08-17.
Age: 95.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest X-ray abnormal, Cough, Full blood count abnormal, Hyperhidrosis, Metabolic function test normal
Clinical narrative: Patient is 95-year old male with history of COPD and lung mass verified by CT for which patient refuses workup, PET scan, PFT, pulmonology consult. Patient received influenza vaccine at local pharmacy. Patient complained that symptoms started after receiving influenza vaccine. Patient was seen in the office on 08/21/2017. Patient reported no specific fever, but drenching sweats. Patient takes O2 2L Q HS and O2 SAT in office was 88% on room air. Patient reported coughing with increasing sputum, yellow on 08/21/2017, but pink the night before.
Age: 95.0
Sex: M
Vaccine: FLUC4
Symptoms: Pneumonia, Productive cough, Sputum discoloured
Clinical narrative: Patient is 95-year old male with history of COPD and lung mass verified by CT for which patient refuses workup, PET scan, PFT, pulmonology consult. Patient received influenza vaccine at local pharmacy. Patient complained that symptoms started after receiving influenza vaccine. Patient was seen in the office on 08/21/2017. Patient reported no specific fever, but drenching sweats. Patient takes O2 2L Q HS and O2 SAT in office was 88% on room air. Patient reported coughing with increasing sputum, yellow on 08/21/2017, but pink the night before.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Swelling, Vomiting
Clinical narrative: A lot of swelling, pain, nausea, vomiting.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Culture urine, Exposure during pregnancy, Full blood count, Head discomfort, Headache
Clinical narrative: Pregnant with baby #4. Typical soreness and warmth over the injection site. Within the following few days I developed a high fever, intense headaches and nausea/vomiting. The symptoms continued for approximately two (2) weeks without relief. Went to Labor & Delivery where they provided medication to reduce the fever & assist with the "migraine"; however, they would not listen when I insisted this was not a migraine. I have a history of migraines. This was more like intense pressure over my entire head with the most pressure at the base of my skull, top of my neck. The medication they provided assisted in bringing the fever down, but did not improve the headache I was experiencing. Although the high fever has since dissipated, I continue to have a low-grade fever nearly every night and sweat it out. In addition, I continue to have a raised bump, similar to a mosquito bite, at the site of injection.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Migraine, Nausea
Clinical narrative: Pregnant with baby #4. Typical soreness and warmth over the injection site. Within the following few days I developed a high fever, intense headaches and nausea/vomiting. The symptoms continued for approximately two (2) weeks without relief. Went to Labor & Delivery where they provided medication to reduce the fever & assist with the "migraine"; however, they would not listen when I insisted this was not a migraine. I have a history of migraines. This was more like intense pressure over my entire head with the most pressure at the base of my skull, top of my neck. The medication they provided assisted in bringing the fever down, but did not improve the headache I was experiencing. Although the high fever has since dissipated, I continue to have a low-grade fever nearly every night and sweat it out. In addition, I continue to have a raised bump, similar to a mosquito bite, at the site of injection.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Night sweats, Pyrexia, Vomiting
Clinical narrative: Pregnant with baby #4. Typical soreness and warmth over the injection site. Within the following few days I developed a high fever, intense headaches and nausea/vomiting. The symptoms continued for approximately two (2) weeks without relief. Went to Labor & Delivery where they provided medication to reduce the fever & assist with the "migraine"; however, they would not listen when I insisted this was not a migraine. I have a history of migraines. This was more like intense pressure over my entire head with the most pressure at the base of my skull, top of my neck. The medication they provided assisted in bringing the fever down, but did not improve the headache I was experiencing. Although the high fever has since dissipated, I continue to have a low-grade fever nearly every night and sweat it out. In addition, I continue to have a raised bump, similar to a mosquito bite, at the site of injection.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Rash generalised, Skin warm, Urticaria, Wheezing
Clinical narrative: Within one hour of receiving Dtap shot, a red welt approximately 2 inches in diameter appeared. 48 hours later the welt had become approximately 4 inches in diameter. 72 hours later the welt had become approximately 8-10 inches in diameter, raised half an inch, very red and warm to the touch. A full body rash as well as wheezing breaths were also present at that point. Called Dr.'s office to report the outcome of the vaccinations. Was told the doctor was not available and put on the phone with the nurse practitioner (unknown name). Nurse practitioner told me that this was not considered a severe reaction and that it's common. She instructed me to do alternating hot and cold compresses and seek emergency services should her breathing become labored. I followed through with the advice as well as administered BENADRYL. The welt took approximately one week after to go away.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cyanosis, Erythema, Flushing, Oxygen saturation decreased, Tachycardia
Clinical narrative: VOMITING SEVERAL MINUTES AFTER RECEIVING VACCINES, SALIVA AND STOMACH CONTENTS. PULSE OXIMETER INITIALLY 91-92% ON ROOM AIR WITHMILD TACHYCARDIA. PATIENT ALERT AND ORIENTED, LUNG EXAM WITH BILATERAL WHEEZING, NO CRACKLES OR RHONCI. POSITIVE FOR FACIAL FLUSHING AND PERIORA CYANOSIS. TRUNCAL SKIN DEVELOPING MILD PATCHY ERYTHEMA, NO TRUE HIVES NOTED. PULSE OX DECREASED TO 89% WITH HR 140S. PATIENT PLACED ON OXYGEN WITH IMPROVEMENT OF SATS TO 100%. PATIENT GIVEN IM DOSE OF EPIPEN JR X 1 AT 4:52PM.  PATIENT WAS ALSO GIVEN BENADRYL  12.5MG/5ML - 5ML PO X1. 9-1-1 WAS ACTIVATED PREVIOUSLY. PATIENT TRANSPORTED BY AMBULANCE TO HOSPITAL. DEXAMETHASONE 10MG GIVEN IM.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting, Wheezing
Clinical narrative: VOMITING SEVERAL MINUTES AFTER RECEIVING VACCINES, SALIVA AND STOMACH CONTENTS. PULSE OXIMETER INITIALLY 91-92% ON ROOM AIR WITHMILD TACHYCARDIA. PATIENT ALERT AND ORIENTED, LUNG EXAM WITH BILATERAL WHEEZING, NO CRACKLES OR RHONCI. POSITIVE FOR FACIAL FLUSHING AND PERIORA CYANOSIS. TRUNCAL SKIN DEVELOPING MILD PATCHY ERYTHEMA, NO TRUE HIVES NOTED. PULSE OX DECREASED TO 89% WITH HR 140S. PATIENT PLACED ON OXYGEN WITH IMPROVEMENT OF SATS TO 100%. PATIENT GIVEN IM DOSE OF EPIPEN JR X 1 AT 4:52PM.  PATIENT WAS ALSO GIVEN BENADRYL  12.5MG/5ML - 5ML PO X1. 9-1-1 WAS ACTIVATED PREVIOUSLY. PATIENT TRANSPORTED BY AMBULANCE TO HOSPITAL. DEXAMETHASONE 10MG GIVEN IM.
Sex: U
Vaccine: HEPA, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (Strength, dose, frequency, route and anatomical location were not reported) of lot/batch # N011491 with an expiry date of 04-NOV-2018, for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 21 hours and 6 minutes. There was previous temperature excursion which involved exposure to 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) for 6 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Lot number N011491 has been verified to be a valid lot number for PNEUMOVAX 23.; Sender's Comments: US-009507513-1708USA007255: US-009507513-1708USA007256:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a 16 year old female patient. Her medical history, concurrent conditions and concomitant medications were unknown. On 19-AUG-2010 and 04-MAY-2012, the patient was vaccinated with first and second doses of human papillomavirus (HPV) vaccination series with GARDASIL (doses, routes, lot #s, and expiration dates unknown) for prophylaxis (inappropriate schedule of drug administration). On 15-AUG-2017, the patient returned to the physician's office for third dose of HPV series with GARDASIL 9 (dose, route, lot#, and expiration date unknown) for prophylaxis (circumstance or information capable of leading to medication error and interchange of vaccine products). No adverse effects were reported. This is one of two reports from the same reporter (1708USA009484 involving the patient's brother).
Sex: U
Vaccine: PPV
Symptoms: Accidental exposure to product, No adverse event, Occupational exposure to product, Product leakage, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacist who reported on them self. On 16-AUG-2017, the pharmacist was administrating a PNEUMOVAX 23 lot # N011305 for prophylaxis. On 16-AUG-2017, the pharmacist experienced occupational exposure to product, accidental exposure to product and product leakage. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA009458:
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of an unknown age. On an unknown date in 2012, the patient was vaccinated with GARDASIL for prophylaxis. Other suspect therapies included GARDASIL 9 administered on 13-APR-2017. On 13-APR-2017, the patient experienced interchange of vaccine products, inappropriate schedule of drug administration and wrong drug administered. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional and refers to unspecified number of patient of unknown age. On unknown dates, those patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M036059 for prophylaxis. No adverse events were reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. On 10-AUG-2017, the patient was vaccinated with PROQUAD injection, lot # N013270 with expiration date of 25-OCT-2018 (dose and route of administration). The vaccine was reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. In May and June 2017, the patients were vaccinated with M-M-R II albumin status rHA, lot # L039613 for prophylaxis. In May and June 2017, the patients experienced incorrect product storage. On an unknown date, the patients experienced no adverse event. This is one of 3 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA009479: US-009507513-1708USA009480:
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age. On 16-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011305 for prophylaxis. On 16-AUG-2017, the patient experienced product leakage and accidental underdose. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA008021:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. In May and June 2017, the patients were vaccinated with VAQTA for prophylaxis. In May and June 2017, the patients experienced incorrect product storage. On an unknown date, the patients experienced no adverse event. It has been determined that lot # M027829 in not valid for VAQTA. This is one of 3 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA009379: US-009507513-1708USA009480:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. In May and June 2017, the patients were vaccinated with ROTATEQ lot # N000175, oral for prophylaxis. In May and June 2017, the patients experienced incorrect product storage. On an unknown date, the patients experienced no adverse event.  This is one of 3 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA009479: US-009507513-1708USA009379:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a 14 year old male patient. His medical history, concurrent conditions and concomitant medications were unknown. On 12-JUN-2014 the patient was vaccinated with first dose of human papillomavirus (HPV) vaccination series with GARDASIL (dose, route, lot#, and expiration date unknown) for prophylaxis. On 15-AUG-2017, the patient returned to the physician's office for second dose of HPV series with GARDASIL 9 (dose, route, lot#, and expiration date unknown) for prophylaxis (inappropriate schedule of drug administration, circumstance or information capable of leading to medication error and interchange of vaccine products). No adverse effects were reported. This is one of two reports from the same reporter (1708USA006990 involving the patient's sister).
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported for two patients. This is the second of two reports. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 07Aug2017 at single dose for immunization and MENACTRA, via an unspecified route of administration on 07Aug2017 at unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced severe headache on an unspecified date. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017360779 same reporter/product, different patient/event.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Pertussis
Clinical narrative: Initial unsolicited case received from other non-health care professional on 10 Aug 2017. This case involves around 4-5 patients (age, and gender not reported) who were vaccinated with a dose of PENTACEL (Batch number, expiry date, dose, dose in series, route, and site of administration were not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, around 4-5 patients developed Pertussis over the last 12 months. The patients' relevant lab tests and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review the company decided to consider the case as serious due to important medical event Pertussis. List of documents held by sender: none.; Sender's Comments: The patients experienced pertussis post vaccination with Pentacel. The time to onset was not known and the event is listed with the vaccine. This case was not considered to be a case of vaccination failure as no information regarding dosing or lab confirmation via PCR or serology was provided. Based upon reported information the role of the vaccine can not be assessed.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Decreased activity, Decreased appetite, Pyrexia
Clinical narrative: On the afternoon of Sunday, July 30, my daughter came down with a fever that ranged from 99 to 101 and lasted for 48 hours. She had low energy, lazed around a lot - when she is normally very active, and her appetite was low. I asked a parent group I am in if the fever could be a reaction to her DTaP even though it was almost two weeks after. The resounding response was YES! And more than one person said to report it to VAERS.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None noted.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4 DAYS LATER (ON AUG 20) THE INJECTION SITE IS TILL RED AND WARM BUT, ACCORDING TO  PATIENT IT IS NOT PAINFUL UNLESS IT IS BEING TOUCHED. SO I ADVISED PATIENT TO TAKE OVER THE COUNTER NSAID AND BENADRYL. AND ALTERNATING WARM AND COLD COMPRESS EVERY 30 MINUTES. YESTERDAY, I CALLED HER AND ASK HOW WAS IT. SHE SAID IT IS NOT AS SWOLLEN AS BEFORE AND IT IS BEING IMPROVED.
Age: 28.0
Sex: M
Vaccine: FLU4, IPV, MMR, MNQ, TDAP, TYP
Symptoms: Malaise, Renal failure
Clinical narrative: Pt received 5 travel vaccines plus seasonal influenza from RN on 9/26/2016. Pt stated that later that night he started feeling sick and went to the ED and was diagnosed with kidney failure and hospitalized for a week.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: 2pm day of immunization, arm sore. By next day afternoon noticed 2x2 swelling and red soreness and warm. By second day post immunization in am, came into to pharmacy and consulted with rph. Recommended Benadryl, took total 4 tablets  one that am (10am), one afternoon (2-3pm) and 2 pm. Third day post immunization complete resolution.